<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![CDATA[Clinical Data Manager - Contract]]> The Senior Clinical Data Manager will be responsible for all of the data management aspects of complex gene therapy clinical trials and will work closely with DM CROs and other third-party providers of data services, Clinical Operations, EDC Developers, Pharmacovigilance, and Data Visualization/Data Repositories. Activities includes all DM aspects of performing and delegating tasks from study start-up to close-out according to the study protocols within timelines with the primary goal of ensuring data integrity and ensuring analysis ready data.

Responsibilities:
  • Leads all data management tasks in support of Phase I – IV complex gene therapy clinical studies from study start-up to database lock
  • Leads development of study specific Data Management Plans, Vendor Management plans, Cross-functional data review plans, eCRF completion guidelines, Data Transfer Specifications, eTMF maps, and other CDM documents as appropriate
  • Authors and reviews operational documentation including project timelines, budgets, target metrics, resourcing forecasts, and quality assurance audit reports
  • Leads eCRF design, edit check programming, SAE reconciliation, Medical Coding, and study documentation management,
  • Leads development of data reports and facilitates cross-functional data review for assigned studies or programs
  • Defines, generates, and analyzes metrics across multiple studies, plans and executes risk mitigation strategies
  • Leads data review for accuracy, completeness, and consistency and performs QC as appropriate
  • Represents CDM at the cross-functional study team meetings, providing risk mitigation strategies and input based on best CDM practices
  • Adheres to study and program timelines and quality standards
  • Participates in process development
  • May lead CDM initiatives
  • Presents eCRF training to clinical study teams, sites, and CRAs at Investigator meetings
  • Mentors new and more junior team members


Requirements:
  • Bachelor’ s degree, preferably in health science or related field and 5-8 years industry experience
  • Has in-depth and breadth expertise in CDM and broad knowledge of Clinical Development, typically developed through extensive experience leading critical organizational initiatives.
  • Recognized as a technical/professional expert and escalation pathway throughout CDO organization.
  • Successfully solves unique and complex problems that have a critical impact on the business.
  • Anticipates opportunities and problems and offers solutions and best practices.
  • Proven track record of designing, leading and executing initiatives that have meaningful impact on critical goals.
  • Contributes to the development of the CDM strategy as a subject matter expert.
  • Strong project management and meeting facilitation skills
  • Demonstrated experience in writing professional correspondence and clinical study documentation
  • GCP knowledge
  • Strong EDC skills, including Medidata Rave and IBM Health
  • Strong understanding of clinical trial data
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions
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Mon, 20 Aug 2018 00:00:00 EDT 0
<![CDATA[Sr. Clinical Data Manager]]> The Senior Clinical Data Manager will be responsible for all of the data management aspects of complex gene therapy clinical trials and will work closely with DM CROs and other third-party providers of data services, Clinical Operations, EDC Developers, Pharmacovigilance, and Data Visualization/Data Repositories. Activities includes all DM aspects of performing and delegating tasks from study start-up to close-out according to the study protocols within timelines with the primary goal of ensuring data integrity and ensuring analysis ready data.

Responsibilities:
  • Leads all data management tasks in support of Phase I – IV complex gene therapy clinical studies from study start-up to database lock
  • Leads development of study specific Data Management Plans, Vendor Management plans, Cross-functional data review plans, eCRF completion guidelines, Data Transfer Specifications, eTMF maps, and other CDM documents as appropriate
  • Authors and reviews operational documentation including project timelines, budgets, target metrics, resourcing forecasts, and quality assurance audit reports
  • Leads eCRF design, edit check programming, SAE reconciliation, Medical Coding, and study documentation management,
  • Leads development of data reports and facilitates cross-functional data review for assigned studies or programs
  • Defines, generates, and analyzes metrics across multiple studies, plans and executes risk mitigation strategies
  • Leads data review for accuracy, completeness, and consistency and performs QC as appropriate
  • Represents CDM at the cross-functional study team meetings, providing risk mitigation strategies and input based on best CDM practices
  • Adheres to study and program timelines and quality standards
  • Participates in process development
  • May lead CDM initiatives
  • Presents eCRF training to clinical study teams, sites, and CRAs at Investigator meetings
  • Mentors new and more junior team members


Requirements:
  • Bachelor’ s degree, preferably in health science or related field and 5-8 years industry experience
  • Has in-depth and breadth expertise in CDM and broad knowledge of Clinical Development, typically developed through extensive experience leading critical organizational initiatives.
  • Recognized as a technical/professional expert and escalation pathway throughout CDO organization.
  • Successfully solves unique and complex problems that have a critical impact on the business.
  • Anticipates opportunities and problems and offers solutions and best practices.
  • Proven track record of designing, leading and executing initiatives that have meaningful impact on critical goals.
  • Contributes to the development of the CDM strategy as a subject matter expert.
  • Strong project management and meeting facilitation skills
  • Demonstrated experience in writing professional correspondence and clinical study documentation
  • GCP knowledge
  • Strong EDC skills, including Medidata Rave and IBM Health
  • Strong understanding of clinical trial data
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions
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Mon, 20 Aug 2018 00:00:00 EDT 0
<![CDATA[Manager, Global Patient Safety Quality & Compliance]]> The Global Patient Safety Department (GPS) Q&C Contract Manager is responsible for supporting the GPS Quality & Compliance activities based on relevant regulations, procedures, and GPS contractual requirements.   Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the management of all GPS SOPs, CAPAs and inspection related activities, as well as leading a QC system for all GPS documents.   The GPS Q&C Contract Manager will manage a global GPS training program, including the implementation, tracking, maintenance, and effectiveness checking of all GPS training activities. The incumbent will support the organization and maintenance of a GPS compliance system with metrics.

Responsibilities: 
  • Support GPS process improvements including the authoring of controlled procedures, maintaining the GPS procedures Index, leading meetings of subject matter experts to revise procedures and merge procedures, to reduce the total number of procedures for improved efficiency, where possible
  • Maintain the GPS project tracking tool for quality and compliance oversight
  • Participate in Pharmacovigilance Agreement creation and revision
  • Support company GPS quality system, which includes supporting the management of all GPS SOPs, CAPAs, and inspection related activities, as well as a QC system for all GPS documents
  • Support the development and management of a quality system/QC for GPS documents including ICSRs, PSUR, DSURs, ad hoc reports, compliance and performance metrics, alliance management and signal detection activities
  • Help to ensure the development, effectiveness evaluations, and compliance with GPS SOPs.  Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure GPS SOP alignment
  • Support Research Quality Assurance (RQA) by engaging and providing support of the RQA pharmacovigilance/clinical safety audit plan, compliance, audit and inspection activities, inspection readiness and other cross functionality
  • Serve as the primary point of contact for GPS controlled documents (i.e. SOPs, WIs, etc.) and GPS training and as the subject matter expert for these topics during audits and inspections
  • Monitor global pharmacovigilance regulatory intelligence to determine impact on pharmacovigilance quality system
  • Assist in monitoring GPS commitments from internal audits, regulatory inspection findings, and CAPAs
  • Contribute to the collection, organization, and presentation of all required global GPS compliance metrics including vendor and partner oversight metrics
  • Lead and support the development and implementation of the global GPS training strategy (training matrix development, process, content, delivery, system, tracking, metrics)
  • Lead and support the development, delivery, implementation, maintenance, and tracking of all GPS training materials including tests for verification of training completion and effectiveness
  • Develop methods to determine the effectiveness of GPS training and initiate improvements as required
  • Represent GPS training on cross-functional learning initiatives and partner with related departments (Learning & Development, IT, Commercial Training, etc.) accordingly
  • Support the development, design & maintenance of compliance metrics, CAPA management for GPS business process, and monitoring of trends with proposed remediation actions
  • Lead and Support GPS compliance and alliance activities
  • Assist in GPS preparation and inspection activities during Regulatory Agency inspections and internal audits
  • Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting GPS, and develop strategies to support the patient safety at the local level
  • Lead projects related to GPS quality, training, and compliance activities, provide GPS compliance and alliance advice and visibility to the company


Job Requirements:
  • Bachelor’ s Degree or equivalent work experience in a scientific or technical discipline
  • Must have a minimum of 5+ years of experience in the areas of GXP regulations with 3-5+ years of experience in a quality and compliance role within pharmacovigilance
  • Quality and compliance background related to Pharmacovigilance
  • Demonstrated analytical and process skills and the ability to apply these skills to GPS organization
  • Effective communication, consulting, customer service and problem-solving skills
  • Must be detail oriented, capability to meet deadlines
  • PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)
  • Excellent time and project management skills
  • Strong interpersonal skills and ability to interact with all levels of the organization and cross-culturally
  • Strategic planning exposure
  • Build positive relationships with regulators, inter and intradepartmental customers, internal and external stakeholders
  • Analyze and interpret regulations and laws and apply to current and future policies and procedures (may include collaboration with other cross functional areas)
  • Global mindset required
  • Demonstrated ability to influence others
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Mon, 20 Aug 2018 00:00:00 EDT 0
<![CDATA[Manager/Associate Director, Program Management]]> Client is seeking a motivated Program Manager to join as a key member of our R&D teams. This person will be responsible for managing the planning and execution of oncology drug discovery programs from First in Human through late phase & pivotal clinical development. This involves organizing and managing a joint global multi-disciplinary team with pharmaceutical partners to deliver high quality data in accordance with budget and timelines. Critical to success is an understanding of the drug development process and a strong ability to drive the collaboration of highly-technical development teams to achieve program goals.

Job Responsibilities
  • Lead the project planning efforts to IND submission and execution of early clinical studies, organize translational and clinical subteams in defining and implementing the asset strategy. Actively manage all aspects and progress of multiple programs towards timely milestone achievement.
  • Direct and ensure communication alignment on technical, organizational, and budgetary affairs with management and our pharmaceutical alliance partner.
  • Manage team operations (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items) Maintain program-related documentation and ensure appropriate archiving and access to shared information and critical program documents Facilitate alignment and cross-functional communication between discovery, late phase research, CMC, Clinical and regulatory to enable the team to meet the program goals Work with the team to develop options, scenarios, recommendations, risk mitigation strategies and integrated operational plans to achieve program objectives Facilitate internal decision-making processes and prepare regular updates for senior management Providing project management support: developing and managing timelines for key projects, developing and implementing processes, ensuring strong lines of communication to the project team and leadership, and ensuring best practices are followed Assisting Project Leaders and Core Team members with complex program deliverables and issue resolution.
  • Supporting optimization of development plans by evaluating assumptions and incorporation of new inputs as the projects progress through development and integration of activities across research including support with resource/budget planning Serve as company representative for project management for partnered research and developmental programs with academic, emerging Biotech as well as our strategic alliance partner


Qualifications:
  • Relevant Scientific Degree (BS, MS or PhD)
  • 5-10 years prior Biotech/Pharmaceutical experience as a program manager preferred with a track record of successfully managing clinical drug development programs
  • Some late phase (Phase 2-3) experience preferred
  • Excellent interpersonal, organization, verbal and written communication skills
  • Problem-solving skills
  • Attention to detail
  • Ability to organize and prioritize tasks in a timely and accurate manner
  • Ability to meet tight deadlines
  • Ability to work collaboratively in a dynamic environment
  • Computer programs systems: Highly Proficient with the following MS Office (Word, Excel, Powerpoint), familiarity with Project Management software, SharePoint and Webex (or other similar systems)
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Mon, 20 Aug 2018 00:00:00 EDT 0
<![CDATA[Director, Alliance Management]]> Client seeking an experienced Alliance Management professional to lead clinical-stage collaborations with leading biotech and pharmaceutical. This Director of Alliance Management will also be tasked with developing the strategy and continued management of future partnerships. This is an exciting time to join a growing company.

Responsibilities:
  • Manage clinical-stage collaborations to ensure that key goals for each alliance are achieved and the value for company and its partners is maximized
  • Manage companion diagnostic partnerships to ensure that development timeline, regulatory path and commercialization plan for CDx are highly coordinated with each clinical development program
  • Create, direct, and execute on a successful alliance management strategy for each collaboration
  • Develop a deep understanding of contractual elements pertinent to each alliance
  • Support near- and long-term alliance objectives while maintaining a broad perspective on corporate strategy and goals
  • Oversee contractual obligations, and be the go-to person internally and for our partners on all alliance-related matters
  • Work closely with and support cross-functional teams to prepare for interactions with our partners. Be familiar and close enough to the details of the programs to manage day-to-day issues and to provide strategic directions to the teams
  • Prepare agendas, manage partner meetings, and document the key discussion points and decisions taken at these meetings
  • Drive and/or assist in the review and creation of inter-company communications
  • Perform regular audits to take the temperature on the alliances
  • Proactively identify potential future issues and develop mitigation plans
  • Identify issues as they arise internally, or as a result of partner interactions, and work with the leadership team and other necessary stakeholders to formulate a position/strategy and participate and/or drive the resolution process
  • Clearly and concisely communicate (both written and verbally) alliance issues and possible resolution to the various internal and partner stakeholders
  • Contribute to final stages of BD deal discussions to ensure that an optimal alliance structure is set up for success, and to prepare for alliance kick-off
  • Develop (along with VP of Corporate Development) and deliver the vision for the alliance management function as we continue to evolve as a company


Qualifications:
  • Prior experience creating and executing on alliance management best practices in the pharma/biotech industry is required
  • Bachelor’ s Degree is required, while an advanced degree (MBA or PhD) is preferred
  • Thorough understanding of the drug development and commercialization process and essential activities across all key functional areas
  • Proven success as a cross-functional leader that is able to influence others
  • Process-minded with the ability to be flexible and nimble when appropriate
  • An energetic, problem solver that is effective at detecting and managing risk, while providing quick responses to emerging problems
  • Ability to travel internationally and domestically on a regular basis
  • Flexibility to accommodate teleconferences outside of regular working hours

Capabilities:
  • Passion for our alliances and for maximizing the value they bring to the company as well as the potential resulting therapies that will be brought to patients
  • Strong ability to identify the reports, processes, and/or template documents that will provide the most value and employ them appropriately
  • Leverage internal and external resources effectively
  • Must be able to earn the trust and respect of executives, scientists, clinicians, administrators, investors, and collaborators while driving the initiatives
  • Must be able to anticipate and resolve organizational, interpersonal, and technical matters including those related to deliverables, intellectual property and contractual obligations
  • Creative problem solver who is articulate and driven to achieve, with a high degree of business savvy
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner
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Fri, 17 Aug 2018 00:00:00 EDT 0
<![CDATA[Manager, Pharmacovigilance Operations]]> Our client is searching for an experienced Manager of Pharmacovigilance (PV) Operations that is a creative, resourceful, and integrative thinker. The Manager of Pharmacovigilance Operations will work on projects and processes that ensure the strategies of the department are executed within global safety legislation and requirements.

The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs, Quality Systems and Medical Affairs.

Roles and Responsibilities
  • Participates in the review and execution of PV Operations safety data collection strategy across clinical trial and commercial programs
  • Provides oversight and review of vendor case processing activities
  • Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all products
  • Provides knowledge into Clinical and Post Marketing teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into studies and commercial activities/programs that may generate adverse event data
  • Participates in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents
  • Accountable for reconciliation activities between Global Patient Safety and Post Marketing programs to ensure reporting of all adverse event data
  • Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication
  • Maintains knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods
  • Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety
  • Undertake activities necessary to maintain a state of inspection readiness
  • Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans
  • Actively participates in the quality review of SAEs and SUSARs following data entry by vendor. Specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from the clinical sites
  • Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned
  • Participates in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes as needed


Experience, Education and Specialized Knowledge and Skills
  • Bachelor’ s degree in nursing, pharmacy, or other health care related profession or life sciences required
  • Master’ s degree in health care related profession preferred, but not essential
  • 5-7 years of direct “ hands on” Drug Safety and Pharmacovigilance experience
  • Vendor management experience
  • Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance
  • Experience using ARISg, Argus or other Safety Database applications required
  • Strong analytical and problem-solving skills with excellent attention to detail
  • Strong verbal, written technical communication and presentation skills
  • Proficiency in standard desktop software programs (Word, Excel, Outlook)
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Fri, 17 Aug 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Clinical Quality Assurance]]> The Associate Director of Clinical Quality Assurance develops, implements and executes procedures to assure that all clinical activities subject to regulatory review comply with internal standards as well as domestic and international regulatory requirements.  This is a leadership position responsible for future development of GCP QA staff and for cross functional collaborations with Clinical Operations and Pharmacovigilance departments.  This position identifies and assesses areas of risk; proposes corrective and preventative action (CAPA) plans, assists with development and implementation of solutions. 

Job Responsibilities:
  • Develop risk based audit plan for conducting QA GCP audits of clinical research activities to assess compliance with applicable regulations, GCP and ICH guidelines, sponsor policies and procedures, study protocols and contracts.  Organize/coordinate the site and vendor audits conducted by external contract auditors, as appropriate.
  • Responsible for conducting audits (both domestic and international) of clinical investigator sites, and vendors, including Clinical Research Organization (CRO), internal product, and system audits.  Assess the compliance of internal and external electronic systems used in clinical research.
  • Partner with Clinical Operations, Pharmacovigilance, and Regulatory Affairs to ensure compliant GCP implementation.
  • Conduct internal audits of clinical study documents such as the Trial Master File, Investigator Brochures, Clinical Protocols, Clinical Study Reports, Case Report Forms, and Informed Consent Forms.
  • Review of Standard Operating Procedures to assess consistency and compliance with regulatory requirements and internal standards, and to determine and ensure effective implementation across the organization.
  • Work with CROs to create quality agreements, ensure quality standards are met, and resolve issues promptly and effectively.
  • Participate in the review of safety and pharmacovigilance practices for clinical compliance.
  • Support the administration of the company’ s training program. Conduct GCP training for clinical team members, investigators, clinical site staff, as needed.
  • Report significant clinical quality deficiencies to QA management when identified.
  • Identify, evaluate, and recommend solutions to problems identified in the performance of QA GCP audits. Prepare clear and concise written reports of audit observations, including an assessment of compliance. Assess adequacy of auditee' s corrective and preventative action (CAPA) plan.  Conduct follow up activities as needed to monitor corrective actions.
  • Support preparation, coordination, and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections.


Qualifications:
  • Minimum of a Bachelors’ Degree in a scientific discipline and at least 8+ years prior experience within the clinical, regulatory, or quality environment in the pharmaceutical or biotechnology industry, with 5+ years specific experience in GCP quality assurance auditing and GCP regulations.
  • Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GCP, ICH guidelines, and HIPAA requirements.  Complete and thorough understanding of regulatory compliance requirements for US FDA, European Union, and Health Canada.
  • Prior experience in conducting compliance audits, development of standard operating procedures, regulatory inspections, and management of quality systems.
  • Must be able to execute job duties with significant degree of independence while effectively collaborating with Clinical Operations, Pharmacovigilance, and Regulatory Affairs departments.
  • Must be available for approximately 15-20% travel annually, both US and international
  • Must have good interpersonal skills and excellent oral and written communication skills.
  • Must have knowledge of clinical safety and clinical trial management systems (e.g. Argus, ARISg, Inform, etc.) as well automated quality systems (ex. Documentum, TrackWise, etc.).
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Fri, 17 Aug 2018 00:00:00 EDT 0
<![CDATA[In-house CRA]]> Client is searching for a resourceful, confident, professional with on-site monitoring experience for an important role as an In-House CRA working on several fast-moving studies for one of our lead programs in the CNS space. The In-house CRA will provide support to study management tasks in collaboration with the Study Manager and/or Senior Managers, with an emphasis on leading monitoring oversight activities for our clinical CROs.

Roles and Responsibilities:
  • Assist the Study Manager in training CRO CRAs and creating the CRA training material
  • Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed
  • Review Monitoring Visit Reports from the CRO
  • Monitor studies (PSV, SIV, IMV, COV) as needed
  • Escalate monitoring trends or findings to the Study Manager
  • Track metrics related to Sponsor Oversight and the Monitoring Plan
  • Assist in start-up activities of clinical research studies including Investigator Meetings, enrollment planning, and Investigator selection
  • Collaborates closely with study management, CRO study managers, and CRO monitoring staff, reviews site/patient activity tracking, prepares study updates and proactively identifies and solves study-related issues
  • Regularly communicates with Investigators to identify and resolve complex clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements;
  • Guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability;
  • Reviews and provides input to study plans and guidelines, including study monitoring plans;
  • Assists in development of study documents, such as informed consent forms, study logs, and study manuals
  • Provide overall tactical support for the study
  • Lead or assist with TMF processes: set-up, training, QC, management
  • Collaborate with CRO counterpart


Education / Requirements:
  • BS/BA degree or equivalent and 4+ years experience in clinical development and operations
  • At least 2 years experience performing on-site monitoring conducting SIVs, IMVs, and COVs for IND regulated clinical research studies.
  • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
  • Demonstrated effectiveness in resolving site management issues of varying complexity
  • Co-monitoring experience required
  • This role will require some travel – ranging from 10% - 50% during peak study activity
  • Strong communication and interpersonal/team skills
  • Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
  • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
  • Excitement about the vision and mission of company.
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Thu, 16 Aug 2018 00:00:00 EDT 0
<![CDATA[Sr. Clinical Project Manager]]> Responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.

Job  Responsibilities:
  • Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
  • Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
  • Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
  • Provides oversight and management of CROs, consultants and vendors.
  • Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
  • Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
  • Monitors the status of clinical data collection of assigned clinical trials.
  • Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
  • Prepares and reviews study-related documents when required.
  • Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
  • Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
  • Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
  • Reviews correspondences and monitoring reports relating to the studies.
  • Prepare and deliver program/study updates.
  • Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
  • Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
  • Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
  • Provides input into contracts, work orders and/or change orders.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
  • Ensures assigned studies adhere to all applicable regulations and requirements.
  • Provides input as the subject matter expert for the assigned studies during regulatory inspections.
  • Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
  • Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
  • Evaluate CRO and vendor performance and support the improvement initiatives.
  • Participate in the preparation, review, updating and training of SOPs.
  • Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.


Qualifications/ Requirements:
  • B.S./M.S./Ph.D. in a related life science discipline is preferred.
  • Thorough understanding of the oncology arena.
  • Minimum of five years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
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Thu, 16 Aug 2018 00:00:00 EDT 0
<![CDATA[Senior Clinical Trial Manager]]> Reporting directly to the Head of Clinical Development, the Senior Clinical Trial Manager will lead the planning and manage the implementation of early and late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model.

If you are looking for a highly visible, high impact role that comes with mentorship from, and exposure to, the highest levels of the organization, it is a great time to join this growing team. You will have the opportunity to not only learn and execute clinical operations in a fast paced, collaborative environment, but to help shape and define it!

This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents and plans. This role will also manage Investigator Sponsored Trials. This position will help review/develop Clinical Operations processes and procedures for a growing department.

Responsibilities:
  • Managing the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines
  • Leading the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
  • Anticipating, recognizing and resolving issues; as necessary, managing escalation of study related issues with management and other R&D functions
  • Contributing to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, trial reports and DSURs
  • Reviewing and approving study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
  • Ensuring audit-ready condition of clinical trial documentation including the trial master file
  • Reviewing monitoring reports to ensure quality and resolution of site-related issues
  • Serving as liaison with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Leading the planning and conduct of investigator’ s meetings
  • Monitoring progress of clinical study activities and reporting on the progress of assigned clinical trials including budget and timelines
  • Performing occasional and periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
  • Participating in the preparation and review of SOPs


Requirements:
  • Bachelor’ s degree is required. Scientific/health care field preferred, but not required.
  • Minimum of 6 years in clinical development in pharmaceutical/biotech industry, at least 3 years of expertise in clinical trial management
  • Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
  • Experience in orphan indications and/or stem cell transplantation will be favorably considered
  • Extensive experience managing complex protocols, CROs, budgets, and timelines
  • Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
  • Strong verbal and written communication skills including clinical authoring experience
  • Ability to organize and manage multiple priorities in a fast-paced, entrepreneurial environment
  • Proven track record of effective leadership with excellent organizational skills and ability to work independently
  • Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
  • Must be willing to travel both domestic and international
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Thu, 16 Aug 2018 00:00:00 EDT 0
<![CDATA[Manager/Sr. Manager Drug Safety/Pharmacovigilance (DSPV) Quality, Compliance and Training]]> Our Client is searching for an experienced Manager of (DSPV) Quality, Compliance and Training that is a creative, resourceful and integrative thinker. The manager will assist with the establishment and maintenance of the Global Quality System for DSPV that supports products in compliance with ICH Guidelines and international regulatory requirements. The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Responsibilities also include assisting in the successful development and implementation of a DSPV Training Program and ensuring compliance with global regulations across all Pharmacovigilance functions. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs and Quality Systems and Medical Affairs.

Job Responsibilities:
  • Develops and maintains policies and procedures for the DSPV Quality System and provides DSPV Quality Assurance support for SOPs, auditing, deviations, training and CAPAs.
  • Leads inspection readiness with the Senior Director of PV Operations and coordinates global inspection readiness activities for PV inspections of global products.
  • Monitors the global DSPV Quality System through metrics and reports.
  • Establish monitoring systems to verify compliance and generate metrics for senior management.
  • Establish procedures for documentation of department compliance and the development of quality assurance plans to improve or maintain data quality.
  • Collaborate with appropriate stakeholders to establish an inspection readiness process for pharmacovigilance and oversee ongoing readiness activities.
  • Monitor adherence and compliance with department documented procedures.
  • Monitoring compliance with worldwide regulations for the reporting of adverse events.
  • Monitor activities of CROs/business partners to ensure adherence and compliance with applicable SMPs, PVAs and other contractual agreements.
  • Develop a DSPV Training Program.
  • Identify relevant quality-related training needs and conduct training as required.
  • Collaborate with management to evaluate the department’ s performance through review of quality reports and compliance metrics and identify solutions for improvement.
  • Assist with audit responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and policies.
  • Participates in DSPV audits of vendors and third parties in global territories and provides oversight for consultants conducting audits on behalf of the Company.


Qualifications/ Requirements:
  • Bachelor’ s degree in relevant field (e.g. Life sciences) or equivalent combination of education and experience.
  • 3-5 years’ experience in Pharmacovigilance compliance preferred.
  • Master’ s degree preferred.
  • Significant prior pharmaceutical or biotechnology drug development experience
  • Comprehensive knowledge of the international pharmacovigilance regulations and requirements, including European Medicines Agency (EMA) Good Pharmacovigilance Practices (GPV)
  • Prior experience managing quality and compliance activities
  • Excellent problem solving and analysis skills; ability to see trends and convert information to insights.
  • Ability to adapt precedent and develop creative and effective solutions to solve problems.
  • Must have experience in working with Pharmacovigilance and/or Pharmacovigilance processes.
  • Excitement about the vision and mission
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Thu, 16 Aug 2018 00:00:00 EDT 0
<![CDATA[Vice President of Accounting]]>
  • eThe VP of Accounting provides management oversight and direction of the organization’ s accounting practices including accounts payable, general ledger, accounts receivable, contracts and grants, property accounting, decision support, budgeting and payroll.


  • Job Responsibilities include:
    • Manage areas of the accounting department and oversee complex accounting transactions.
    • Provide oversight and training to the general accounting staff regarding accounting procedures, general ledger system maintenance and controls over accounting entries.
    • Design and implement a documented system of internal controls throughout the organization. Manage the decision support team to deliver financial and operational reporting and analysis to support multiple lines of business.
    • Manage the annual independent audit and the preparation of financial statements and tax returns.
    • Develop materials for and participate in Audit and Finance Committee meetings.
    • Participate in the annual budget process including issuing guidelines and procedures; training staff, auditing budgets, overseeing data input and preparing reports.
    • Prepare financial projections and modeling related to organizational financing alternatives.
    • Prepare or supervise the preparation of outside reports and filings.

    Job Requirements include:
    • Bachelor’ s Degree in Accounting with 10 years of progressive management experience
    • Master’ s Degree in Accounting, Finance or Business.
    • CPA required.
    • Strong financial and information systems experience and acumen.
    • Knowledge of A-133 federal award regulations, restricted gift accounting and reporting requirements, contracts and grants accounting, and tax-exempt bond accounting and compliance.
    • Demonstrated experience developing and implementing policies, procedures and best practices; training others regarding those policies; and overcoming resistance to change.
    • Experience in systems design, implementation, monitoring and managing.
    • Experience with financial statement preparation, analysis, forecasting, modeling and budgeting in a multi-location environment.
    • Experience working in a cross-functional and highly matrixed organization.
    • Experience working in a healthcare, academic and/or not for profit organization a plus.
    • Computer savvy: skilled and comfortable with query and reporting tools; advanced skills with Microsoft Office applications, especially Excel.
    • Detail oriented with strong quantitative analytical skills.
    • Proven ability to multi-task and remain flexible to accommodate changing operational needs.
    • Superb communication skills (written and verbal), sound judgment and ability to learn quickly while working in a dynamic environment.
    • Ability to work collaboratively with diverse groups, maintain confidentiality and think strategically.
    • Access to personal mode of transportation; Ability to travel within the region on a frequent basis.
    ]]>
    Wed, 15 Aug 2018 00:00:00 EDT 0
    <![CDATA[Senior Marketing Manager ]]> Our client - a global, not-for-profit Association - is looking to add a  Sr. Marketing Manager  to their team on a permanent basis.  The ideal candidate will have extensive knowledge of product marketing and management in the B2B technology space. This individual will have broad experience in product marketing and management, communicating and educating customers on products, and serving as a product evangelist, to marketing and industry professionals.

    Job Responsibilities include:
    • Collaborate with departmental teams (product management/research) to identify opportunities to promote the Association’ s products and content globally in addition to increasing brand awareness in the area of membership and certifications.
    • Develop and maintain strong product family and portfolio value propositions for specific vertical market end users and potential partners.
    • Develop and manage relationships with marketing agencies and third-party marketing vendors.
    • Maintenance, forecasting and tracking of monthly budgets.
    • Prepare and execute marketing campaigns including concepts, message maps, promotion plans, work flow schedules and cost estimates.
    • Work with business partners to deliver product marketing collateral and product sales tools, such as product presentations, digital and print ads, brochures, product value proposition and competitive positioning documents.
    • Develop and retain an excellent working knowledge of the organization, its member programs and benefits.
    • Manage, develop and coach marketing coordinators.
    • Identify key industry events.
    • Monitor industry and technology trends and suggest items or topics as candidates for public relations activity in conjunction with the communications team.

    Job Requirements/Qualifications Include:
    • Bachelor’ s degree in marketing or related field
    • Minimum of 15 years of marketing management experience in technology arena
    • Proven regard for data integrity and ability to work with IT and Operations partners in extracting data for analysis purposes
    • Proven computer skills including Word, Excel, PowerPoint; some knowledge of iMIS, iMIS marketing modules preferred
    • Excellent verbal/written communication skills across all levels of management
    • Agency management
    • Message development in a content or knowledge based marketing environment
    • Ability to develop and manage a budget
    • 5 years of experience managing staff
    • Ability to analyze data for marketing decision making purposes
    • Proven project management skills; strong organizational skills with the ability to handle multiple projects at once while completing quality work on a timely basis
    • Travel (when requested); but limited
    ]]>
    Tue, 14 Aug 2018 00:00:00 EDT 0
    <![CDATA[HR Manager]]> Support the strategic direction of the company by developing a positive and high performance team culture. This role encompasses the entire range of HR administration and employee relations, implementing and administering policies and programs in recruitment, organizational planning, training and development, employee relations and communications. 

    Job Responsibilities
    • Ensure staffing of qualified employees by developing and managing recruitment, interview, selection and on-boarding process, including intern programs.
    • Serve as a link between management and employees by handling questions and helping to resolve work-related issues.
    • Organize and lead HR team at assigned locations by communicating expectations; planning, monitoring work, assessing results; enforcing policies and ensuring quality and productivity standards are achieved.
    • Take lead role in designing and facilitating on boarding programs, including management training and leadership development.  
    • Evaluate and recommend training resources to support employee development. 
    • Administer performance management program.


    Qualifications/Requirements
    • Ability to work effectively with all levels of employees and management.
    • Ability to handle multiple projects simultaneously while maintaining quality standards.
    • Excellent organizational, leadership, interpersonal and communications skills.
    • Positive and professional demeanor, cooperative personality with ability to participate effectively in a collaborative team environment.
    • Optimize work of assigned department(s) and balance the work load appropriately; develop and implement efficiencies to improve the work flow; develop and oversee the training, development and evaluation of assigned staff and ensure smooth teamwork with other functions; and, ensure high quality standards are established and maintain
       
    ]]>
    Tue, 14 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director of Program Management]]> The Program Director position is a high impact, hands-on leadership role with responsibility for significant elements of program strategy and cross-functional execution. This role requires a talented individual with proven expertise in leading global cross-functional teams and driving major initiatives. This individual, in partnership with the Program Team members, will drive program strategy and ensure clear and timely communication of program strategy, implementation plans, and progress.

    Responsibilities
    • Lead cross-functional program team(s) to develop strategic plans for compounds integrating development, commercial, technical and financial considerations
    • Drive program team decision-making and management of early stage compounds to better understand the science and establish clinical development plans
    • Apply oncology drug development knowledge and experience to ensure that product candidates are managed in the efficient and rigorous manner as reflected in the design and conduct of studies with a high degree of technical, regulatory and commercial success
    • Lead scenario planning and organizational readiness for initiatives and/or projects, as required
    • Work closely with Translational Medicine and Research groups on the search for and identification of biomarkers, and coordinate development of biomarkers in parallel with drug development effort
    • Ability to translate cross-functional program issues into functional implications
    • Be responsible for issue identification and development of an action plan for resolution. Escalation to functional leadership and/or R&D Leadership, when needed.
    • Monitor and track program budget; escalate significant budget changes through the functions impacted; advocate for additional resources when needed for program success
    • Drive effective and impactful communication related to program strategy to ensure active management of issues/risks/decisions/opportunities related to all internal and external activities
    • Ensure collaboration across the Program Team to achieve maximum team effectiveness


    Qualifications/ Requirements
    • Requires a minimum of 7 years R&D program management experience leading cross-functional teams
    • Experience in early clinical stage drug development in the oncology or imuno-oncology area required, with the understanding of the development process and regulatory requirements for in vitro diagnostics (IVDs) highly desirable
    • Lab experience with biomarker assays, particularly pathology/immunohistochemistry, flow cytometry, and DNA/RNA sequencing desirable.
    • Understanding of CAP/CLIA/GLP/GCP clinical diagnostics environment desired
    • Life sciences degree required; advanced degree preferred
    • Strong analytical and creative problem-solving mindset
    • Ability to make or drive decisions rapidly when the situation calls for it.
    • Ability to identify key priorities, align strategic and tactical plans, and motivate cross-functional teams and drive effective partnerships across functions
    • Outstanding relationship building and communication skills, including ability to navigate throughout the organization rapidly and with individuals at all levels
    • Managerial experience and proven effectiveness within matrix structures and within cross functional global teams.
    • Strong holistic perspective of drug development process and life cycle management across different functional areas including familiarity with commercial, medical affairs, clinical and pharmacology, preclinical research, finance, regulatory and compliance groups
    • Strong program management skills required
    ]]>
    Tue, 14 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director, Patient Advocacy]]> Our client is seeking a Director, Patient Advocacy. Reporting to the Vice President of Corporate Affairs, the Director of Patient Advocacy will drive engagement with patient advocacy groups across the company’ s portfolio, gather patient insights to inform our clinical development programs, develop and implement strategic programs and partnerships, and champion the patient perspective within the company. The right candidate will be an excellent communicator with an ability to develop meaningful relationships, a strategic thinker that can bridge the complexities of patient care and drug development, a seasoned collaborator who can successfully lead and influence external and internal stakeholders, and a highly motivated self-starter who is comfortable innovating in an entrepreneurial and fast-paced start-up company environment.

    Responsibilities:
    • Champion the patient perspective and provide strategic insights to internal teams to foster understanding; bring to life the core value “ patients first” by directly connecting employees to the patient experience
    • Contribute to the company’ s evolving philosophy and long-term vision for patient engagement
    • Develop strategic plans for engaging global patient communities across the company portfolio, with an emphasis on clinical-stage programs
    • Represent the company and its programs at meetings and other interactions with patient advocacy groups and disease communities
    • Serve as a key relationship manager for global patient advocacy groups and manage regular communications to ensure productive partnerships
    • Identify, initiate and oversee strategic patient advocacy programs and partnerships related to disease awareness and education, diagnosis, access to appropriate care, and policy advocacy, in collaboration with a cross-functional team –
    • Support clinical trial awareness and patient identification initiatives across the portfolio to support rapid trial enrollment and execution
    • Lead or contribute to the development of patient-facing educational materials across the organization
    • Partner with medical affairs and clinical to ensure patient inquiries about our programs are rapidly and consistently addressed with accurate and compliant information
    • Oversee handling of requests and manage budget for patient advocacy group sponsorships, grants and charitable contributions
    • Partner effectively with critical cross-functional partners including commercial, medical affairs, clinical, research, legal, and regulatory; provide leadership to external partners and manage specific vendor projects


    Qualifications:
    • Bachelor’ s degree required; advanced degree preferred (e.g., MS, RN, PhD, or MD)
    • Minimum 5 years of direct patient advocacy experience in the biopharmaceutical industry; overall 10 years of relevant industry or non-profit experience
    • Experience in oncology and/or rare diseases
    • Strong understanding of patient care models, drug development and regulatory processes, and commercialization of therapeutics
    • Exceptional communicator skilled at relationship building and expressing empathy for patients and families in need; highly perceptive, socially intelligent, and intuitive
    • Strong leadership skills with a proven ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making without authority
    • Highly motivated individual with the flexibility and creativity to excel in a rapidly growing and changing environment; confidence and organizational skills to independently work on multiple tasks
    • Must be willing and able to travel (approximately 30%) and regularly meet with patient advocacy organizations in the U.S. and internationally

     
    ]]>
    Mon, 13 Aug 2018 00:00:00 EDT 0
    <![CDATA[Senior Director, Program Management - Pipeline Strategy]]> This role is highly cross-functional, and will involve collaboration with external partners, along with involvement from company senior leadership. The Senior Director of Program Management & Pipeline Strategy is charged with monitoring and managing portfolio deliverables and progress with related milestones, identifying gaps, monitoring market dynamics, competitive intelligence and making strategic recommendations.

    Job Responsibilities:
    • Advance the strategic development of the company’ s pipeline, including the company’ s gene therapy platform, its PMO/PPMO pipeline assets and its on-market therapy for treatment of Duchenne Muscular Dystrophy
    • Support R&D strategy to expand current indications and enter into new disease areas
    • Lead development of goals for asset teams and sub-teams to ensure alignment with corporate goals
    • Lead and coordinate strategic off-sites and pipeline annual reviews
    • Align budgets and financial planning to corporate strategy and priorities
    • Drive process and accountabilities for creation of key cross-functional deliverables and milestones
    • Modify strategic recommendations based on current status of programs and risk factors
    • Proactively identify gaps and areas of opportunity and work cross functionally to fill gaps.
    • In partnership with cross-functional partners, conduct rigorous, fact based quantitative analyses to expedite robust decision making across the programs & portfolio
    • Create and utilize modeling methodologies that will interrogate the portfolio and R&D resources to support internal platforms/programs and external investment opportunities
    • Work with finance to support development of long-range plan, including investment requirements.
    • As member of the Program Management Team will provide aligned and consistent communication across the organization at all levels
    • Provide risk assessment on timing of data and readouts to support investment decision making
    • Support vetting of alternative development options across team
    • Orchestrate the integration of sub-teams to support the efforts of the Asset Teams


    Qualifications/ Requirements:
    • BS in technical discipline, Advanced degree preferred
    • At least 10-15 years’ experience with demonstrated success in leading large-scale programs with proven results and effective leadership and management skills
    • Extensive knowledge and experience in R&D - ability to define, develop and implement portfolio strategies based on trends, opportunities, needs and market direction within pharmaceutical industry and/or health care environment.
    • Operational experience in investment optimization models, asset valuation and portfolio assessment techniques.
    • Strong financial, budget and resource planning experience
    • Ability to articulate and establish processes which impact cross-functionally
    • Demonstrated success in leading through influence
    • Demonstrated ability to integrate information and apply creative thinking and proactive problem solving skills
    • Demonstrated ability to identify, build, and implement solutions to cross-functional team issues
    • Excellent balanced approach to process versus results-driven leadership and management skills
    • Excellent negotiating skills
    • Excellent communication and influencing skills up, down and across the organization
    • Strong business, analytical and planning skills
    ]]>
    Mon, 13 Aug 2018 00:00:00 EDT 0
    <![CDATA[Senior Director, Program Management - Pro]]> With a successful on-market treatment and an industry-leading pipeline, client is seeking an individual who will provide super leadership and program management of company Global Asset Teams with emphasis on its Technology platform and oversight of its research program for an ultra-rare disease. The successful candidate should possess a scientific background and demonstrate understanding and experience in drug development and the regulatory requirements to plan, execute and deliver both NDAs and INDs to global regulatory authorities in this novel therapeutic area.

    This role is highly cross-functional, and will involve collaboration with external partners, along with involvement from company senior leadership. The Sr. Director, Program Management is charged with having a command over the strategy and supporting critical path/activities, risks, contingencies and alternatives and proactively managing daily program/project management activities, including schedule development, budget, communication, status reporting, and resource plan development. The ideal candidate has strong communication and influence skills, ensuring that all team members understand priorities, objectives, deliverables, interdependencies and timelines.

    Job Responsibilities:
    • Build and advance the development of integrated strategic Global Asset Plans with focus on its Technology platform, along with the supporting the advancement of the development program for an ultra rare disease
    • Lead development of program critical path, decision criteria and milestones/decision gates platform in order to support the launch of new therapeutic options for patients
    • Prioritize asset-level deliverables and align across functions
    • Develop and ensure accuracy of Global Asset timelines, align with each line function’ s plan
    • Lead development of goals for teams to ensure alignment with corporate goals
    • Drive process and accountabilities for creation of key, cross-functional deliverables
    • Modify strategic recommendations based on current status of programs and risk factors
    • Proactively identify operational and program issues, drive cross functional resolution, and Partner with functions and finance to maintain accurate Global Asset forecasts and ensure robust budget process
    • Lead team in the implementation of cross-functional program risk management plans including risk and opportunity identification, mitigation strategies and contingency planning.
    • Provide risk assessment on timing of data and readouts to support investment decision making
    • Lead vetting of alternative development options across team
    • Orchestrate the integration of sub-teams to support the efforts of the Asset Teams
    • Support continuous improvement efforts with lessons learned, updated governance


    Requirements:
    • BS in technical discipline, Advanced degree preferred
    • At least 8-10 years’ experience with demonstrated success in leading large-scale programs with proven results and effective leadership and management skills
    • Demonstrated program management expertise and experience; project management certification preferred
    • Demonstrated success in leading through influence
    • Demonstrated ability to integrate information and apply creative thinking and proactive problem solving skills
    • Demonstrated ability to identify, build, and implement solutions to cross-functional team issues
    • Excellent balanced approach to process versus results-driven leadership and management skills
    • Excellent negotiating skills
    • Excellent communication and influencing skills up, down and across the organization
    • Strong business, analytical and planning skills
    ]]>
    Mon, 13 Aug 2018 00:00:00 EDT 0
    <![CDATA[Clinical Project Manager ]]> The Clinical Project Manager is responsible for the successful execution of clinical trials from protocol conception through the clinical study report. The Clinical Project Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

    Job Responsibilities:
    • Manages clinical operations aspects of clinical studies
    • Clinical Trial Overall:
      • Develop comprehensive study timelines and metrics
      • Develop and manage study budget within financial goals
      • Prepare and present project debriefings, as required; plan, execute, and lead or participate in study-specific meetings
    • Vendor Management:
      • Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations
      • Assist in the selection and evaluation of study personnel (contract and internal)
      • Provide study-specific training and leadership to clinical research staff, and other contract personnel;
      • Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs
      • Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics
    • Site Selection and Management:
      • Participate in site and country selection. Develop relationships with investigators and site staff.
      • Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments
      • Manage clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations
      • Participate in site monitoring visits as appropriate
    • Uses operational and therapeutic expertise to optimize trial design and execution:
      • Design clinical trial protocols with study team consistent with clinical development plan
      • Develop ongoing data review plan to ensure data trend detection and study objectives are met
      • Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc.
      • Prepare and/or review study-related documents: Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completion Guidelines
      • Provide input and support documentation for adverse event safety monitoring while collaborating FDA and regulatory authorities report submissions
      • Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution
    • Ensures all clinical trial execution within compliance of international GCP guidelines/regulations and SOPs:
      • Participate in planning of QA activities and coordinate resolution of audit findings
      • Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issues
      • Coordinate and assist regulatory or ethics committee activities planning
      • Provide staff oversight maintaining clinical trial master files to ensure appropriate compliance
    • Lead and consistently be present for the Cross-Functional Study Team as well as internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)


    Skills & Requirements:
    • Bachelor’ s Degree (health, biologic science or related field) required; Master’ s Degree preferred
    • Minimum of 5 years clinical study management experience in biopharmaceutical industry, including at least 2 years as a clinical study lead/project manager, required
    • Prior experience managing contracted resources/CRO required
    • Site monitoring and clinical data review highly preferred
    • Clinical quality compliance experience highly preferred
    • Advanced knowledge of GCP and current knowledge of CFR for IND clinical trials required
    • Knowledge of ICH and other country regulatory requirements is preferred
    • Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required
    ]]>
    Mon, 13 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director, Pharmacovigilance Compliance]]>
    Responsibilities:
    • Establish Metrics and other monitoring systems to measure and verify compliance for senior management.
    • Leads PV inspection readiness activities and coordinates for global inspection readiness.
    • Maintain and update the PSMF with QPPV and Head of PV.
    • Develop and maintain a PV Quality System for Standard Operating Procedures, auditing, CAPAs.
    • Assisting in the development, implementation and management of a PV training program.
    • Work with Quality Assurance and other functions to establish pharmacovigilance activities in the company.
    • Identify gaps in Pharmacovigilance, solutions, and monitor completion.
    • Develop with SMEs and maintain SOPs.
    • Develop and maintain Pharmacovigilance Agreements and Safety Data Exchange Agreements. Monitor compliance with required activities according to executed agreements.
    • Monitor aggregate/periodic report compliance, reconciliations; monitor quality, timeliness and performance; assist in process.
    • Manage EEA QPPV and local QPPV communication, etc.
    • Manage training and documentation for PV department and PV training company-wide, vendors, etc.


    Requirements:
    • Bachelor’ s or Master’ s Degree in Health or Medical sciences, degree in Pharmacy, Nursing or Public Health a plus
    • 5-10 years experience in Drug Safety / Pharmacovigilance with at least 3 year compliance experience preferred
    • Global PV regulation experience is preferred.
    • Ability to maintain positive relationships with management, peers and cross-functional departments
    • Traits include critical thinking, sense of urgency, diplomacy and professionalism.
    • Recognized by former peers, colleagues, managers and direct reports for attributes congruent with
    ]]>
    Fri, 10 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director of Learning and Development]]> The Director of Learning & Development will assess training and development needs and create solutions that enhance and sustain the organization' s  talent and leadership capability. This position will be critical to enabling organizational performance and effectiveness by implementing strategies and programs focused on continuous learning and development. The Director will collaborate with senior leaders to implement talent initiatives that engage, align, develop and retain the necessary talent to achieve strategic goals.

    Job Responsibilities

    Design & Development
    • Partner with the VP, Human Resources  to establish organizational development and talent management strategies that will ensure leadership continuity and career progression for employees
    • Conduct organizational needs analyses, collaborating with business unit leaders, and recommend proposed solutions to meet business challenges
    • Design innovative learning and development programs to strengthen individual skills and competencies, and drive a culture of continuous learning and improvement
    • Leverage state-of-the-art instructional design methods to deliver engaging, outcome driven learning experiences

    Delivery, Facilitation & Project Management
    • Expertly facilitate training programs and blended solutions
    • Manage the successful delivery of projects and initiatives using an effective balance of internal and external resources
    • Manage outside training vendor relationships and oversee the implementation of training courses designed by outside vendors, ensuring alignment with company objectives
    • Establish pre-training and post-training metrics, training evaluation tools, program effectiveness assessments and address needs for improvement where necessary
    • Lead the Performance Management Process and ensure it delivers against the requirements of a fair and objective measurement of employee performance, is simple and efficient, and drives a performance based organizational culture  

    Learning Administration
    • Lead the effort to research, select and implement a Learning Management System
    • Create and maintain learning events and activities; maintain course descriptions, calendars, rosters, and schedules
    • Identify opportunities to streamline, simplify, and improve learner / participant experiences

    Job Qualifications

    Required
    • Bachelor’ s degree in Human Resources or a related area
    • 10 years of experience in developing and delivering talent development and training programs, including leadership development and performance management
    • Highly collaborative with the ability to build strong relationships across all levels within the organization
    • Excellent facilitation skills
    • Experience using a variety of e-learning approaches; basic abilities in Articulate, Captivate or other e-learning development tools
      Preferred
    • Master’ s degree
    • Previous experience starting up a training function
    ]]>
    Wed, 08 Aug 2018 00:00:00 EDT 0
    <![CDATA[Manager/Associate Director, Quality Systems Vendor Management and Oversight ]]> Client is seeking a highly motivated, collaborative, resourceful, and results oriented Manager to support commercial and development GxP activities within the Quality Systems organization. The successful candidate will be responsible for managing vendor oversight systems and programs in support of pharmaceutical development, process development, analytical development and GCP clinical oversight.

    Job Responsibilities:
    • Provide oversight of GxP Vendor Management Program.
    • Manage and maintain the GxP Vendor Management Plan, including risk-based auditing strategy.
    • Establish acceptability of Vendors for potential use by company; evaluate strategic partners and suppliers across commercial and development programs (GMP, GLP, GCP, and GPV).
    • Devise GxP audit schedule, oversee execution of audit plans and audits, reviews audit reports, and track corrective/preventive actions associated with key vendors in accordance with applicable regulations, guidelines and SOPs.
    • Manage individual consultant auditors to ensure that all audits, resultant reports and other work product are of acceptable quality and in compliance with company requirements.
    • Monitor performance/compliance issues identified across Vendors. Elevate systemic problems with appropriate recommendations/solutions to upper management for immediate and long-term resolution across company.
    • Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures related to clinical and bioanalytical suppliers. Provide appropriate risk analysis for key stakeholders to make critical decisions.
    • Design and manage a Quality System SharePoint page to collaborate and communicate with cross-functional teams to drive timelines and maintain vendor information, audits and other Quality Systems programs up to date.
    • Continually evaluate the strategic approach, drive change in the Quality Systems audit program to meet the changing needs of the organization, regulatory environment and industry best practices.
    • Ensure required aspects of the Quality Vendor Management System are trended on a routine basis for presentation to senior management for review
    • Support the build of continuous improvement to the Quality System to ensure regulatory and industry standards are met.


    Qualifications/ Requirements:
    • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
    • Minimum 5 years of applicable pharmaceutical drug development/clinical/pharmacovigilance experience.
    • Direct experience in conducting and/or leading the following types of audits: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), and CMOs.
    • Experience with quality systems and activities at all phases of the Product Lifecycle.
    • Experience building relationships and working with external Vendors.
    • Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
    • Knowledgeable of GxP regulations particularly GCP, GLP, GVP and GMP.
    • Outstanding communication skills (interpersonal, verbal and written).
    • Proven track record of industry success.
    • Strong leadership and management skills.
    • Excellent teamwork and collaboration skills.
    • Excitement about the vision and mission.
    ]]>
    Tue, 07 Aug 2018 00:00:00 EDT 0
    <![CDATA[Senior Manager Human Resources, Plant Operations]]> The person in this role will manage  the day-to-day and long-term operations of the Human Resources department, including Health and Safety, Employment, Employee Relations, Benefits, and Security. S/he will also ensure  compliance with State and Federal labor laws, as well as site  compliance with EEO requirements. 

    Job Responsibilities:
    • Acts as liaison between area management and employees.  Provides advice and counsel to Managers, Supervisors and employees (employee advocate) regarding personnel practices, policy, and employment laws (coaching/counseling, problem resolution, administration of progressive discipline policy).
    • Develops and administers the site' s employee relations program which includes Employee Appreciation events, Company Sponsored events and Employee Communications.
    • Directs the development of staffing strategies from temporary staffing to executive placement.
    • Administration of company benefit program at a site level - ensures company benefit programs are communicated and understood by employees.
    • Responsible for the site' s Health and Safety programs and compliance with OSHA regulations.
    • Responsible for the site' s security program which includes protection of employees, their personal property and company assets.


    Job Qualifications/ Requirements:
    • Four-Year college degree in Human Resources or related field required and 7+ years of progressive HR experience.  Requires a thorough knowledge of employment and labor laws and OSHA regulations.
    • Must possess excellent communication skills (verbal and listening).  Proven leadership with the ability to exercise sound judgment in making decisions.
    • Computer literate using business software (Word, Excel, Lotus Notes) required.
    • Professional certification a plus – PHR/SPHR
    ]]>
    Tue, 07 Aug 2018 00:00:00 EDT 0
    <![CDATA[Associate Director, Medical Writing]]> Our client is seeking an Associate Director, Medical Writing. Reporting to our Vice President, Medical and Technical Writing, the primary deliverables for this role are clinical regulatory documents according to applicable regulations. It is envisioned that this person will play a leadership role in future key regulatory submissions to the FDA and EMA. This will be full time, onsite role.

    Job  Responsibilities:
    • Provide leadership in planning and completing key submission documents (e.g., Clinical Summaries of Safety and Efficacy, Clinical Overview) for submissions to the FDA and EMA
    • Contribute to overall project management and to cross functional working groups (clinical operations, clinical development, data management, statistics) as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
    • Manage the work of CRO contract writers, as needed
    • Work with the clinical and regulatory teams to prepare protocols, clinical study reports, Investigator’ s brochures, safety updates, and IND clinical sections in CTD format under strict timelines
    • Participate in recruiting and mentoring of staff, and budget planning


    Requirements:
    • PhD in a Life Science or equivalent
    • At least 5 years in medical writing, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA)
    • Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections
    • Demonstrated ability to communicate and write clearly, concisely, and effectively
    • Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high? quality documents according to tight timelines
    • Wide knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
    • Proficient in Microsoft Word; familiarity with Excel, QUOSA, and PleaseReview an advantage
    • Accurate and detail-oriented
    • Aptitude for compilation, analysis, and presentation of data
    • Independently motivated, and good problem-solving ability
    • Ability to work with multiple contributors to produce a final unified document
    ]]>
    Mon, 06 Aug 2018 00:00:00 EDT 0
    <![CDATA[Manager, Regulatory Affairs ]]> Serves as the primary regulatory interface with Partners and internal teams.  Ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all regulatory requirements.   Develops and oversees the regulatory strategy, preparation and review of FDA Submissions including NDA’ s, ANDA’ s, Amendments and Labeling changes. Ability to make decisions that may have implications on the strategy, management and operations of an area within a department. 

    Success for this role would be measured primarily by the following:
    • Provide in-depth and timely Regulatory strategy/input for all new development projects and in-licensing projects
    • Accurate interpretation and implementation of the regulatory requirements leading to the highest quality regulatory submissions.
    • Timely submission of new regulatory applications and amendments.
    • Preparation and submitting high quality and accurate new original applications and amendments to secure timely application approvals. 
    • Reductions in time to market as a result of continuous operational improvement initiatives
    • Ensuring the quickest possible approval and launch of new products.
    • Effective communication with all levels of staff across all departments and partners
    • Develop, apply, and report on department and regulatory metrics.
    • Any additional responsibilities as assigned by Scientific Affairs/Operations Management


    Responsibilities:
    • 90% - Involved in all aspects of regulatory affairs from outlining the data requirements for new original applications.
    • Develops regulatory strategies, prepares and reviews dossiers for FDA submission including NDAs, ANDA’ s, Amendments, Supplements, and DMF’ s in line with regulatory requirements, regulatory guidelines, and GMP compliance.  Determines and approves data requirements, regulatory reporting categories, and gathers, assembles and reviews documentation and data from partners as needed to support submissions.
    • Serve as product regulatory expert for Product Development, Project Management, Marketing, Sales, Business Development, teams and partners as needed. 
    • Ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all regulatory requirements.
    • Reviews, administers and approves change control process by reviewing proposed changes against most recent applicable filings to ensure regulations, guidelines, and commitments are satisfied.
    • 10% - Management of specific regulatory affairs programs and systems which may include:
    • Management of the procedures and process including training staff.
    • Manage quality systems within Regulatory Affairs including performance management metrics, standard operating procedures, documentation storage, database development and management for regulatory tracking.


    Qualifications:
    • BS / Pharm D in Pharmacy, Biology, Chemistry, and Microbiology required. Advanced degree preferred
    • 3-5 years of regulatory affairs experience, focusing on parenteral dosage forms with emphasis on product development, product due diligence, regulatory strategy for new products and FDA communication.
    • Direct experience in preparing CTD format and electronic ANDA submissions to the FDA required.
    • Regulatory publication eCTD software experience preferred.
    • Solid knowledge of all aspects of regulatory pharmaceutical drug development process and life cycle management including strong command of CGMP’ s/FDA regulations, FDA Guideline documents, USP, ICH and other applicable laws.
    • Direct experience in preparing CTD format and electronic ANDA submissions to the FDA required.
    • Able to clearly articulate regulatory strategy at partner and project management meetings. Able to negotiate with partners to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
    • Pharmaceutical development knowledge and understanding of various dosage forms, parenteral dosage forms preferred.
    • Experience in product due diligence for new development projects and in-licensing projects
    • Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills and ability to interact with all levels of management.
    • Experience successfully negotiating directly with the FDA, partners and internal teams.
    • Effectively prioritize workload and manage time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced environment.
    • Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
    ]]>
    Mon, 06 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director HR/Total Rewards ]]> POSITION PURPOSE
    The position is responsible for leading and planning the day-to-day operations of various group benefits programs, such as group health, dental, vision, short-term and long-term disability, life insurance and accidental death, flexible spending plan, 401(k) plan, and Canadian pension plan. Also responsible for administering company compensation programs, including merit planning, STI/LTI and SERP.

    PRINCIPAL ACTIVITIES
    • Compensation Administration
      • Lead the annual compensation and bonus distribution planning process to ensure successful delivery, competitiveness and alignment with company philosophy to drive a high performance culture.
      • Manage STI and LTI programs.
      • Manage the SERP program in partnership with external vendor.
      • Develop a job evaluation process that includes market competitiveness and internal alignment are at company standards for fair and equitable pay across all positions.
      • Recommend plan design enhancements to ensure compensation programs provide a competitive total rewards package.
      • Oversee the annual merit review process ensuring accurate and timely development of the plan.
    • Benefit Administration
      • Manage the annual healthcare renewal process in partnership with company broker, ensuring programs are keeping up with market trends while remaining cost effective.
      • Investigate, recommend and implement plan design modifications and/or new programs and present recommendations to the benefit committee.
      • Serve as primary contact for plan vendors and third-party administrators. Determine the best plan options by working with the Third-Party administrators. Coordinate transfer of data to external contacts for services, premiums, and plan administration. Work effectively to make sure the plans run smoothly. Investigate discrepancies and provide information in non-routine situations.
      • Ensure compliance with applicable government regulations.
      • Participate in the implementation of global projects, including: total compensation, mergers and acquisitions, and HIPAA, as they relate to group benefit issues.
      • Analyze the current benefits, evaluating the usage, services, coverage, effectiveness, cost, plan experience, and competitive trends in benefits programs, and identify the company’ s stance.
      • Survey industry trends. Complete benefits surveys and review information obtained from the results. Analyze complex benefits information. Forecast trends and assist with future benefits designs. Develop specific recommendations for review by management.
    • 401(k) Administration
      • Direct the efforts of 401(k) third party administrator, ensure plan operates smoothly and efficiently including timely processing of quarterly statements, timely deposit of employee contributions.
      • Monitor changes in the law and work with 401(k) administrator to ensure the plan document and SPD are legally compliant and reflect plan practices and procedures
      • Participate as a member of the 401(k) committee and coordinate quarterly committee meetings.
    • HRIS Administration
      • Manage the ongoing relationship with Ceridian Dayforce
      • Identify areas for additional employee and management training on the Ceridian Dayforce application.
      • Ensure configuration updates in Ceridian Dayforce are completed in a timely and accurate manner.
      • Identify enhancements to Ceridian Dayforce to ensure the most effective use of the system across the company.
      • Monitor the accuracy of the data entry into the system.
      • Ensure business process flows are working properly (i.e. carrier feeds, scheduled reports, workflow, benefit enrollments, etc).
    • Organizational Development
      • Oversee training and organizational development programs to ensure employees receive relevant and engaging training opportunities
      • Oversee the performance management process
      • Oversee employee recognition programs.
    • Manage corporate HR staff
      • Coordinate and oversee daily benefit processing.
      • Oversee enrollments, COBRA, terminations, changes, beneficiaries, disability, accident and death claims, rollovers, QDROs, QMCSOs, distributions, loans, hardships, compliance testing.
      • Manage immigration, employee relocation, 401(k) administration, annual enrollment and the employee Wellness program.
      • Oversee maintenance of employee benefit files and updating of employee payroll records.
      • Oversee the processing of monthly billings and the preparation of vouchers for payment of administrative fees for all group plans.
    • Canadian Programs
      • Manage the administration of the Company’ s Central Pension Plan.
      • Manage supplemental retirement programs including RRSP, EPSP, and DPSP
      • Manage company’ s Canadian healthcare program and renewal process.
    • Customer Service, Communication
      • Actively promote an understanding and appreciation of Total Rewards program, including the creation and deployment of an ongoing communication strategy and programs to educate leaders and managers.
      • Provide customer service support.
      • Provide training and support to the field HR staff.

    JOB REQUIREMENTS
    Required
    • Bachelor’ s degree and a minimum of 8 to 10 years’ experience in compensation and benefits. Benefits experience should include healthcare, dental, life insurance, disability income continuation and 401(k).
    • A strong customer service orientation.
    • Prior vendor management experience.
    • Excellent communication and organization skills.
    • Experience developing and managing HRIS/ electronic record keeping systems. Prior system implementation a plus.
    • Project and team management/leadership skills and experience. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
    • Strong analytical skills, a thorough knowledge of plan designs, and knowledge of the benefits legal environment.
    • Computer proficiency and technical aptitude with the ability to utilize MS Word, Excel, PowerPoint.
    • Knowledge of benefits contract language.
    • Knowledge of all pertinent federal and state regulations, filing, and compliance requirements both adopted and pending affecting employee benefits programs, including ACA, ERISA, COBRA, FMLA, ADA, SECTION 125, Workers Compensation, Medicare, OBRA, and Social Security and DOL requirements.

    Desirable
    • PHR and CEBS professional designations preferred
    • Previous supervisory experience
    • CCP and CBP
    ]]>
    Mon, 06 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director, Business Development]]> As a member of the Business Development team, this position will focus on growth of the company by supporting the Senior Director, Business Development in identifying and executing transactions resulting in new products. The individual will be expected to identify, drive and execute on opportunities linked to the overall strategic plan of the company.

    Job Responsibilities:
    • Identify viable business targets.  Seek out potential product acquisitions, licensing opportunities, alliances, co-development opportunities and collaborations which support the broader business strategy.   Utilize a strong network of multinational generic drug industry relationships to gain access to the most interesting potential transactions.
    • Prepare detailed evaluations of opportunities.  Pull together assessments of targets, including financial forecasts and models, competitive environment and strategic fit.    Also, lead and coordinate internal resources for due diligence, including input on the legal, regulatory, quality, manufacturing and product development aspects of potential transactions.
    • Develop and negotiate deal terms / agreements.  Work effectively with other key functions in the organization to develop proposals to present to prospective partners. Lead negotiations that ultimately result in favorable business arrangements for the organization.
    • Serve as a champion to ensure operational effectiveness / organizational buy-in.  Work cross functionally to improve organizational efficiency around overall deal execution, including assessment of processes.
    • Cultivate and expand the positive business relationships with key senior executives of international development and supply network partners. 
    • Evaluate the pharmaceutical market and identify new areas of growth.


    Qualifications and Experience:
    • Bachelor’ s degree is required.
    • The successful candidate will ideally have at least 3-4 years of experience in business development and licensing roles in the generic drug industry.
    • A strong network of contacts and relationships in the generic pharmaceutical industry.
    • Multinational transaction experience and perspective, evidenced by a track record of sourcing and/or executing transactions with entities outside the US.
    • A demonstrated ability to multi-task and to individually accomplish large amounts of work. The candidate will be expected to drive multiple initiatives at one time in a fast moving environment where the expectations to always deliver results will be high.
    • A track record of effectively presenting business development transactions to senior management.
    • A demonstrated track record of effectively working cross-functionally with peers and their organizations.
    • Good executive presence and communication skills.
    • Travel Requirements:  15%; Possibly International
    ]]>
    Mon, 06 Aug 2018 00:00:00 EDT 0
    <![CDATA[Sr. Clinical Trial Associate]]>
    Primary Responsibilities:
    • Ensure compliance with protocol and overall objectives across all investigator sites
    • Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
    • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
    • Execute study activities according to study protocol, regulatory guidelines and operational plan
    • Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
    • Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
    • Participate in study start-up, conduct and closeout activities
    • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
    • Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
    • Assemble and distribute regulatory binders to clinical sites
    • Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
    • Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers.
    • Assist with preparation and distribution of investigator site contracts and budgets
    • Maintain the Trial Master File for all clinical projects


    Skills & Requirements:
    • Bachelor’ s Degree in health sciences related field, RN, or related discipline required
    • Minimum 3-5 years relevant experience
    • Excellent written and verbal communication skills
    • Strong PC skills (MS Word, MS Excel, MS Project)
    • Sound analytical and problem-solving skills
    • Act with consistent sense of urgency with acute attention to detail.
    • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
    • Exceptional organizational and time management skills
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Clinical Trial Associate Manager ]]> The Clinical Trial Associate Manager is a line management position. This role will be filled by a CTA who is a highly-skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and providing oversight to CTA activities and input and guidance to study teams across all ongoing clinical studies. The CTAM may be integrated into a study team based on program needs. Based on experience, the CTAM assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the CTAM independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The CTAM is responsible for providing guidance, mentorship, and training for more junior team members. The CTAM will conduct regular performance reviews with direct reports and will make recommendations regarding resourcing and career progression to Management.

    Primary Responsibilities:
    • Ensure compliance with protocol and overall objectives across all investigator sites and studies
    • Ensures project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines are developed and maintained
    • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
    • Ensures execution of study activities according to study protocol, regulatory guidelines and operational plan
    • Reviews Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
    • Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
    • Participates in the planning and execution of study start-up, conduct and closeout activities
    • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
    • Provides oversight for the collection and review of site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
    • Provides oversight for the assembly and distribution of regulatory binders to clinical sites
    • Provides oversight for the development of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
    • Provides oversight for project management activities ensuring consistency and completion of tasks such as taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers
    • Assist with preparation and distribution of investigator site contracts and budgets
    • Provides oversight for the maintenance of the Trial Master File for all clinical projects


    Skills & Requirements:
    • Bachelor’ s Degree in health sciences related field, RN, or related discipline required
    • Minimum 3-5 years relevant experience
    • Excellent written and verbal communication skills
    • Strong PC skills (MS Word, MS Excel, MS Project)
    • Sound analytical and problem-solving skills
    • Act with consistent sense of urgency with acute attention to detail
    • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred
    • Exceptional organizational and time management skills
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Clinical Research Associate II]]> The CRA II is a self-motivated individual able to work in a small-team environment and to independently identify tasks/issues of critical importance. In this role, you will develop a thorough knowledge of GCP, ICH and CFR principles. The successful candidate will be a highly-organized individual who can multitask and adjust direction based on changing project/corporate priorities.

    As the primary point of contact for investigator sites, the CRA II ensures the clinical trial is conducted according to appropriate guidelines and protocols. You will be responsible for the efficient execution of monitoring and other clinical trial management activities while tracking the progress of assigned studies and project. Proactively identifying potential challenges, the CRA II develops appropriate actions to resolve issues and achieve target objectives.

    Primary Responsibilities:
    • Perform investigator site pre-study site qualification visits including collection of site regulatory documents
    • Assist with site start-up activities including site contracts and budget development/negotiation and preparation of IRB submissions (including follow through to successful outcomes)
    • Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
    • Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
    • Participate in/lead Investigator/Initiation Meetings and ensure that the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in-line with protocol requirements
    • Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).
    • Track movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories or movement of samples to sample management storage
    • Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters, or other potential creative solutions)
    • Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication
    • Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
    • Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment
    • Identify and complete follow-up of SAEs at study sites
    • Assist with data listing, data coding and patient profile reviews, database lock, and site close-out activities
    • Ensure appropriate and timely submission of documents to the Trial Master File


    Skills & Requirements:
    • Bachelor’ s Degree in health sciences related field, R.N., or related discipline, required
    • Minimum 2-4 years field-based monitoring or other relevant experience
    • Thorough knowledge of ICH/GCP guidelines
    • Strong written and verbal communication ability
    • Strong PC skills (MS Word, MS Excel, MS Project)
    • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
    • Experience with Outsourced Clinical Trials required
    • Ability to travel 25-50% required
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Clinical Trial Associate II]]> The CTA II assists the study team across all investigator sites and ensures compliance with protocol and overall clinical objectives. The experienced CTA II performs project/study management-related responsibilities by coordinating and tracking activities for clinical trials in compliance with protocol, Standard Operating Procedures (SPOs) and regulatory guidelines from the inception of the protocol through the database lock process. To accomplish this, the CTA II works closely with all functional areas as well as with external providers to ensure consistent, high-quality outcomes.

    Working independently on most assignments while only typically requiring instructions on new assignments, the CTA II understands that this is a role where additional growth and learning is integral. The successful candidate is highly organized and identifies tasks/issues that need to be addressed while multitasking and adjusting direction based on changing project/corporate priorities.

    Primary Responsibilities:
    • Ensure study activities are executed according to study protocol, regulatory guidelines and operational plan.
    • Review Investigational Drug Brochures (IDB), Protocols, Case Report Forms (CRFs) and informed consent forms (ICFs) for a thorough understanding of the study drug and procedures.
    • Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
    • Participate in study start-up, conduct and closeout activities
    • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
    • Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.).
    • Assemble and distribute regulatory binders to clinical sites
    • Draft and/or assist with the preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
    • Support project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study status trackers
    • Assist preparation and distribution of investigator site contracts and budgets
    • Maintain the Trial Master File for all clinical projects


    Skills & Requirements:
    • 2-3 years of experience in industry.
    • Experience in a CRO or Sponsor preferred.
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Project Manager, Biologics and Immunotherapy]]> The Project Manager, Biologics and Immunotherapy will lead global, multi-disciplinary project teams focused on the research, development and commercialization of T-cell receptor-engineered T cells (TCR-T) and metabolic treatment of cancer. This role may work closely with a key strategic partner on projects that are being jointly developed.

    Job Responsibilities:
    • Set up, lead and develop projects.
    • Provide regular reports to executive management to track projects.
    • Manage documentation flow of projects.
    • Contributing intellectually to and assuming accountable for appropriate design and implementation of a various preclinical studies to be conducted both internally and externally.
    • Responsible for summarizing and interpreting results of studies with respect to their impact on the development drug candidates.
    • Tracking of expenditure within the projects.
    • Participating, either hands-on or through the management of CRO’ s or collaborators, in the execution of various preclinical studies (e.g., pharmacokinetic studies, efficacy studies, in vitro assays, safety, ADMET, or chemistry-related studies) associated with drug discovery and development.
    • Work collaboratively within highly integrated, multi-functional program teams encompassing development (clinical, manufacturing sciences, pharmacology, clinical supply as well as biology and chemistry research teams).
    • Contribute and write regulatory documents to support preclinical, clinical, and clinical pharmacology submission to various regulatory agencies.
    • Stay abreast of literature, government guidelines, internal guidances related to preclinical development.
    • Identification and due diligence of external assets for potential acquisition and development
    • Identification and presentation of proprietary projects to potential development partners and management of due diligence.
    • Ability to produce and present quality scientific papers at external meetings and for publication.
    • Ability to frame issues, ask the right clarifying questions, and rationalize decisions.
    • Leverages experience/judgment to integrate information from team members/key advisors to make decisions. Builds productive relationships with  team members.
    • Manages integration points with team members to ensure alignment. Effectively interfaces with functional areas to ensure strategic alignment and to obtain appropriate operational resources to deliver on goals. Ensures appropriate decisions are made in a timely manner at the appropriate levels to drive deliverables.


    Required Education & Qualifications:
    • Advanced degree (PhD) in Immunology preferred. Other disciplines that will be considered are Cell Biology, Oncology, Pharmaceutical Sciences, or closely related fields.
    • 5+ years’ relevant industry experience in a biopharmaceutical setting with extensive experience leading drug discovery teams.
    • Knowledge of the structure/function of tumor targeting receptors such as T cell receptors (TCR).
    • Experience in building partnerships and leveraging relationships with internal scientific teams to drive execution of research strategies.
    • Experience with or exposure to the composition and filing of Investigational New Drug Applications.
    • An understanding of all functional areas of drug development, including; chemistry biology, toxicology, clinical development, diagnostic development, etc.
    • Manages and prioritizes multiple projects, provides solutions to complex problems and delivers complete and accurate information within deadlines.
    • Ability to work effectively in a highly collaborative, multi-disciplinary team setting.
    • Accomplishes goals under project time lines.
    • Excellent written and verbal communication skills.
    • Experience using Microsoft Project as a project planning and tracking tool to successfully manage projects.
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Clinical Project Manager]]> As a Clinical Project Manager (CPM), you will work in a matrix management environment and serve as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee CRO conduct and progress when outsourcing is required. The CPM understands all aspects of project management and ensures that the study meets projected milestones within budget. The CPM may assist the director in managing and implementing project management team meetings.

    Job Responsibilities:
    • Coordinate the standardization and maintenance of status reports and other information sources.
    • Facilitate communication with external partners and key therapeutic area investigators when issues arise that affect multiple projects and/or TA(s).
    • Work with project leadership to facilitate cross-functional team and multiple business-partner communication for proactive study-wide problem solving regarding study progress and trial issues.
    • Participates in the development of risk mitigation strategies.
    • Coordinate with project leadership to identify and notify appropriate parties of emerging out of scope activities.
    • Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operational processes.
    • Provide input into the development of the CRF (data capture forms) design and completion instructions.
    • Collaborate with the TA(s) management staff & cross-functional management teams, in development of budgets and timelines for new studies.
    • Performs ongoing vendor management (e.g. CROs, IVRS) including independent negotiation of vendors scope of work and budgets, performance management and issue resolution.
    • Ensures accuracy and timeliness of vendor and site payments.
    • Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on a temporary basis as needed to move project deliverables and timelines forward.
    • Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
    • Review visit reports and escalate issues to medical and operational leaders.
    • Ensures trial adherence to ICH/GCP/local regulations.
    • Calculate clinical and non-clinical IMP requirements.
    • With cross-function departments to ensure timely manufacture, packaging and IMP shipment to sites.
    • Facilitate SAE medical review process.
    • Assist medical and project leaders with safety reporting compliance.
    • Coordinates data cleaning activities.
    • Reviews query aging reports against timeline and works with functional team members or CRO to resolve queries according to plan.
    • May review clinical data (listings and tables)
    • Have an understanding of IND/NDA submission requirements.
    • Assist with the review and revision of new and revised IND documents.
    • Conduct quality control (QC) audits on annual and ad hoc IND updates.
    • Serves as functional manager for contract study monitors


    Required Education & Qualifications:
    • Bachelor of Science (applied science) or registered nursing degree (Masters preferred).
    • At least three years of experience in clinical trial project management.
    • Excellent project management skills.
    • Direct and positive experience communicating with Clinical Operations teams and study sites.
    • Must have excellent organizational skills and work effectively in a fast paced environment.
    • Must possess good analytical and researching skills.
    • Must be proficient in Microsoft Word, Excel, Office and MS Project.
    • Ability to education and train junior staff.
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Statistical Programmer]]> Provide Statistical Programming Support for Clinical Data Analysis and Submission.

    Job Responsibilities:
    • This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials.
    • Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputs
    • Create annotated CRFs, mapping specifications and datasets per SDTM standards
    • Review analysis data specifications and create ADaM analysis datasets per Statistical Analysis Plan and ADaM data standards
    • Review Table/Figure/Listing shells for Clinical Study Report and produce tables, figures and listings accordingly
    • Perform program validation for external vendors and/or internal staff, as appropriate
    • Ensure that each statistical reporting deliverable has necessary and sufficient documentation as required by the company’ s SOPs


    Required Education & Qualifications:
    • Bachelor’ s degree in Biostatistics, Statistics, or Relevant Fields required; Master’ s degree preferred
    • 1 to 3 years of experience in statistical data reporting for clinical studies
    • Strong SAS programming skills
    • Knowledge in creation of CDISC SDTM and ADaM data structures
    • Have strong verbal and written communication skills in English
    • Prior experience in therapeutic area of Oncology is preferred
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Statistical Programmer, Clinical Pharmacology]]> Provide efficient and effective programming solutions required for clinical trial analysis and reporting, including understanding major components of study protocols, creation of more complex datasets, creation of graphs using more advanced programming skills, understanding and application of more advanced statistical tests, perform basic quality-checklist code reviews, develop standardized programs to automate routine tasks; and design, write and debug macro routines.

    Job Responsibilities:
    • Provide statistical representation on project and protocol teams.
    • Participate in the protocol development process, including responsibility for sample size calculations and the statistical section of the protocol.
    • Perform bioequivalence analysis and ad hoc statistical analyses, when needed.
    • Responsible for preparation of analysis plans, tables, figures and listings for inclusion in clinical reports.
    • Perform exploratory data analyses based on requirements provided by scientists or specified in analysis plans. The results from exploratory data analyses may be used for further data characterization, such as logistic regression or time-to-event analyses.
    • Create SAS datasets of clinical data from clinical databases, create project specific macros and formats. Proficiently create complex and difficult datasets, based upon study protocols, data analysis plans, and dataset requirements.
    • Participate in the evaluation and validation of SAS macros and template programs related to the creation and validation of standard submission datasets, as needed.
    • Develop standard macros and/or tools in SAS for data analysis and reporting.
    • Write, run and debug programs and macro routines.
    • Understand and apply the concept of data disposition to datasets created.
    • Validate results produced by external vendors and/or internal staff, as appropriate.
    • Participate in the writing, review and finalization of CSRs, abstracts, and manuscripts for publication.
    • Provide input and support on data and submission standards to project teams to ensure high quality and timely deliverables that meet industry standards and regulatory requirements; particularly with regard to STDM and CDASH standards, statistical programming conventions, and CTD-CRT preparation (Define.xml development, CRF annotation, FDA submission expectations and SDTM compliance rule violation resolution).
    • Ensure data compliance by following the established guidelines of national and international regulatory authorities.
    • Comply with, follow and maintain documentation of all policies and standard operating procedures as specified in the company’ s Quality Management System and Software Development Lifecycle.
    • Participate in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
    • Identify routine problems; provide recommendations based upon analysis of the situation for assigned projects.
    • Automate and streamline statistical analysis processes.
    • Understands complicated study designs from vast experience with various study designs, disease states, and dataset structures.
    • Recognize anomalies in data input and program output and able to communicate this information effectively.
    • Collaborate closely, mentor and communicate clearly with project team members of the Biostatistics, Data Management, Clinical Pharmacology and Regulatory departments on various clinical projects.
    • Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.


    Required Education & Qualifications:
    • Minimum of 2 to 3 years of experience as a Clinical/Statistical SAS Programmer in the pharmaceutical, or related, industry. SAS Certification desirable.
    • Master of Science degree in Statistics or related field is required.
    • Strong SAS (Base/Graph/STAT) and SAS Macro programming skills with understanding and experience preferably in a clinical data environment.
    • Proficient in industry standards (CDISC), medical terminology, and clinical trial methodologies.
    • Strong understanding of relational database structure.
    • Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for regulatory submissions.
    • Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
    • Demonstrated teamwork, organizational, innovative problem solving and interpersonal skills required; strong verbal and written communication skills in a global environment is also necessary for success.
    • Able to work independently, exercise judgment in interpreting, modifying and adapting procedures, practices, methods, etc.

     
    ]]>
    Fri, 03 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director, Pharmacovigilance Operations]]> This position serves the primary focus of creating the global Pharmacovigilance (PV) department and will be responsible for the PV Operations activities globally across all products in clinical development and on the market. The incumbent will be joining the growing PV department and be an integral member of the PV leadership team reporting directly to the Vice President and Head of PV.

    Responsibilities include a strategic and tactical approach to management and oversight of the company’ s PV Operations processes for both investigational and marketed products in compliance with internal SOPs and applicable global regulations and guidelines. This person needs to be highly motivated and is expected to provide innovative, critical, and strategic input and leadership.

    Primary Responsibilities:
    • Manage the PV Operations function.
    • Organize and oversee the receipt, evaluation, processing, documentation and reporting of adverse event information from clinical trials, investigator sponsored trials, post-marketing, etc. sources.
    • Manage and oversee PV vendor. Monitor performance and compliance.
    • Support ongoing safety surveillance of company products.
    • Contribute to regulatory submissions, aggregate reports, investigator communications, labeling, etc. as needed.
    • Develop and implement PV training programs for internal and external needs and monitor compliance.
    • Provide safety and pharmacovigilance expertise in-house for products in development and marketed products.
    • Oversee preparation and quality control activities for safety case processing activities performed internally and by vendors or contractors.
    • Lead development of standard operating procedures for safety and internal compliance
    • Manage license partners, vendors, etc. with PV Agreements and Safety Data Exchange Agreements.
    • Liaise with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and Legal.
    • Support the Head of Pharmacovigilance develop and implement appropriate drug safety programs and processes


    Requirements:
    • Healthcare degree in nursing or pharmacy
    • Minimum 10 years’ experience in PV operations
    • Ability to build relationships and influence across disciplines and all levels
    • Global experience is required.
    • Occasional travel required.
    • Thorough knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA and ICH guidelines.
    • Knowledge of MedDRA, WHO DD
    • Experience with Argus and ArisG
    ]]>
    Wed, 01 Aug 2018 00:00:00 EDT 0
    <![CDATA[Senior Medical Director, Pharmacovigilance - Safety Medical Review]]> Our client is seeking an experienced Senior Medical Director of Drug Safety and Pharmacovigilance (DSPV) that is a creative, resourceful and integrative thinker. The Senior Medical Director serves as the global lead for the pharmacovigilance and risk management of assigned investigational and/or marketed products. This is a highly visible role that will interface across all levels of management and functional areas and is responsible for developing the safety strategy and the identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

    Roles and Responsibilities
    • Lead product safety surveillance strategy and activities for assigned product(s)during all phases of the product life-cycle
    • Represent DSPV on the product program team(s)
    • Maintain knowledge of therapeutic area diseases and assigned product(s) safety and efficacy profile
    • Ensure that routine signaling activities assessment and investigation are completed and documented per SOPs
    • Respond to safety-related queries from regulatory authorities, IRBs/ECs
    • Lead product benefit-risk assessment discussions at Safety Governance Committee
    • Includes needed actions to update Reference Safety Information or risk minimization actions
    • Lead DS&PV representation for clinical development of the assigned product(s) including:
    • Clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data
    • Safety content of IB, Reference Safety Information, ICF
    • Regulatory filings (ISS, Benefit-Risk, RMP/REMS as required)
    • Responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR)
    • Conduct medical review of individual case safety reports (ICSRs)
    • Includes appropriate follow-up requests and accuracy and timeliness of expedited reports
    • Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’ s business strategy, industry standards and compliance with global regulations


    Experience, Education and Specialized Knowledge and Skills
    • MD, MD PhD or MD MPH required
    • Minimum of 5-7 years’ experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry-extensive postmarketing safety experience preferred
    • Sound clinical acumen and decision making
    • A proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency.
    • Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
    • Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing
    • Demonstrated leadership and collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.
    • Excellent oral and written communication skills
    • Prior experience contributing to the development (process improvement, training, etc.) of a drug safety would be desirable
    ]]>
    Wed, 01 Aug 2018 00:00:00 EDT 0
    <![CDATA[Sr. Medical Director/Medical Director]]> Our client is seeking a Medical Director to oversee the planning and execution of clinical trials and the interpretation of clinical trial data. The successful candidate will be responsible for successful execution against agreed clinical development plans.

    To be successful in this role, the individual will be self-motivated, must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines. The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging company that depends on strong links and collaboration with contract research organizations, academia and nonprofit organizations.

    Roles and Responsibilities
    • Contributes to the design and leads the execution of clinical studies, including writing clinical protocols and major amendments, designing of data collection systems and preparation of final clinical study reports.
    • Represents Medical Science on assigned Study Management Team(s) as the Study Medical Lead, providing medical input to all aspects of clinical trial execution.
    • Participates in the Clinical Sub Team, as directed by the Program Medical Lead.
    • Responsible for providing or supervising medical monitoring activities for all human clinical trials, Phases I– IV, for company products under development.
    • Responsibilities also include support of adverse event reporting and patient safety.
    • Provides medical information for inclusion in reports submitted to regulatory authorities.
    • Supports the authoring of appropriate regulatory documents.
    • Engages with KOLs for the design of clinical trials.
    • Contributes to the assessment of benefit/risk
    • Ability to manage external organizations.


    Requirements
    • Medical degree and 2-5 years broad bio/pharmaceutical industry experience in drug development or equivalent. Industry and/or IND experience strongly preferred.
    • Knowledge of Neurology, Anesthesia and/or Psychiatry.
    • Orphan drug/fast-track experience desirable.
    • Knowledge of the drug development process
    • Strong understanding of technical, business, and regulatory issues.
    • Diplomacy and professionalism, ‘ clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicines to patients.
    • Able to effectively interface with clinical operations and other disciplines.
    • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the Company.
    • Ability to work independently as well as part of a team environment.
    • Proven ability to manage multiple projects, identify and resolve issues.
    • Ability to influence without authority, lead change and manage resistance to change.
    • Must be able to solicit information, persuade others and shape outcomes.
    • Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs.
    ]]>
    Wed, 01 Aug 2018 00:00:00 EDT 0
    <![CDATA[Director, Project Management ]]> With a successful on-market treatment and an industry-leading pipeline, our client is seeking an individual who will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific product development and major regulatory submissions (e.g., NDA, MAA), in order to advance pipeline programs on behalf of the company. The successful candidate should possess a scientific background and demonstrate understanding and experience in drug development and the regulatory requirements to plan, execute and deliver both NDAs and INDs to global regulatory authorities.

    This role is highly cross-functional, and may involve close interaction with external partners. The Director of Program Management is charged with having an in-depth understanding of critical path/activities and interdisciplinary connections necessary to complete specific major regulatory submissions. The ideal candidate has strong communication skills, ensuring that all team members understand priorities, objectives, deliverables, interdependencies and timelines.

    Job Responsibilities:
    • Build, drive and maintain project and major regulatory submission plans that delivers tangible results in advancing the company’ s pipeline, ultimately leading to commercial launch of key assets.  
    • Facilitate team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans and major regulatory submissions.
    • Develop and maintain detailed program and major regulatory submission milestones and oversee the process for content draft, review and delivery according to identified timeline proactively identify and prioritize program risks, and develop and monitor risk mitigation/contingency plans.
    • Oversee adherence to program budgets and regulatory submission project plan timelines and deadlines.
    • Manage interdependencies across functions, including clinical, non-clinical, regulatory and CMC to support execution of project plan and major regulatory submissions.
    • Lead data-driven decision-making in order to make timely, solid, objective recommendations for continuation, acceleration, reprioritization, redesign or termination of projects, along with necessary change management recommendations.
    • Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
    • Communicate effectively to team members and executives through written, verbal and project summary updates, providing line of site to key issues and accomplishments


    Qualifications/ Requirements: 
    • Demonstrated ability to drive projects to completion
    • BS in technical discipline, Advanced degree preferred
    • 10+ years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, or regulatory affairs with significant exposure to global teams
    • 5+ years of experience in program management/leadership of cross-functional teams
    • Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, investment, capacity) to achieve aligned corporate objectives with a “ sense of urgency”
    • Self-directed individual who can work both independently and through a cross-functional team in a fast-paced environment, fostering open communication, mutual understanding and cooperation within the company and with external vendors
    • Solution-based thinker with a “ can do”/” do-what-it-takes” attitude, coupled with superb organizational and communication skills
    • Strong interpersonal skills with the ability to motivate others and direct activity from a position of informal influence, negotiate during conflict situations, and forge consensus between competing points of view
    • Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, PMIS)
    • Represents attributes reflective of company Values: Patient focused, bias for action, commitment to excellence, empowered people, and integrity.
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Associate Director, Program/Project Management]]> This individual will work closely with internal cross-functional teams to ensure execution of the strategy managing specific projects/programs, and facilitating all stakeholder communication. The ideal candidate will have a scientific background, experience with drug development and operations. This role is highly cross-functional, and will involve close interaction and collaboration with external partners. The individual should possess an in depth understanding of cross-functional R&D projects, and will be responsible for creation of project plans, identifying and tracking critical path/activities, risks, contingencies and alternatives. The Associate Director/Director, Program /Project Management will proactively manage daily program/project management activities, including schedule development by function and integration across projects and programs, budget, communication, status reporting, and resource plan development for certain selected larger projects. The ideal candidate will drive alignment to overall priorities, objectives, deliverables, interdependencies and timelines to remain on track by executing against pipeline strategic plan.

    Responsibilities:
    • Serve as project manager for drug development teams with focus on PMO platform and Gene Therapy, providing leadership, coordination, and cross-functional communication to enable teams to meet their aligned goals through improved, cross-functional decision making
    • Lead cross-functional program teams (for multiple drug candidates), including representatives from clinical, nonclinical, regulatory, and CMC, to execute on the drug development strategy
    • Identify and track all CMC projects requiring cross-functional support
    • Provide focus for the cross-functional team through visibility to an integrated project plan to ensure all stakeholders are aware of key program activities; to frame important strategic and tactical issues and contingencies; and to ensure timely decision-making
    • Work closely with all team members to apply project management processes such as definition, initiation, planning, execution and risk management.
    • Integrate Analytical Chemistry, Process Development, Manufacturing, Supply Chain, Clinical, Quality, and Regulatory requirements and constraints into overall project plans
    • Lead data-driven decision-making in order to make solid, objective recommendations for continuation, acceleration, reprioritization, redesign or termination of projects, and change management recommendations.
    • Develop and maintain detailed program milestones and timelines, proactively identify and prioritize program risks, and develop and monitor risk mitigation/contingency plans
    • Facilitate team meetings to drive cross-functional communication, decision making, and successful execution of program and accountability to commitments and timelines
    • Apply Project Management best practices, from development of agenda, to distribution of meeting summaries, to follow up of all relevant action items
    • Proactively identify opportunities for improvement to team effectiveness, processes, communication and/or program outcomes
    • Report on program progress/change and elevation of issues/delays, as appropriate, to management
    • Ability to draft slide decks and dashboards for program strategy reviews, Executive, and BoD updates.
    • Understand and leverage inter-department dependencies and handoffs
    • Foster strong relationships with team members and functional line managers, and serve as key point person for program team members on project-related communications and issue identification and management
    • Program budget tracking (together with finance representative), including approval of changes that arise throughout the year due to changing conditions/plans within the program


    Qualifications/Requirements:
    • BS in technical discipline, Advanced degree preferred
    • 5-10 years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, regulatory affairs or project management with significant exposure to global teams
    • Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, financial investment, manufacturing and organizational capacity) to achieve aligned corporate objectives with a “ sense of urgency”
    • Self-directed individual who is able to work independently with limited direction while working successfully in a cross-functional environment.
    • Must be a solution-based, creative thinker with a “ can do”/” do-what-it-takes” attitude and superb organizational and communications— both written and oral
    • Demonstrated leadership in clinical-stage drug development settings with strong analytical skills and entrepreneurial drive
    • Highly collaborative team player who fosters open communication, facilitates mutual understanding and cooperation with all stakeholders
    • Strong interpersonal skills with the ability to motivate others, to direct activity from a position of informal influence, to negotiate conflict situations, and to forge consensus between competing points of view
    • Must have the ability to work well as part of a team in a fast paced environment and foster open communication, mutual understanding and cooperation within the company and with external vendors
    • Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, PMIS, etc.
    • PMP certification preferred
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Director Supply Planning & Optimization ]]> Leading and managing operational excellence / optimization projects in conjunction with the internal/external supply chain partners, regulatory and quality teams.  The position manages continuity of supply by optimizing business processes and driving the CMO manufacturing and batch release schedule.  The primary focus is to make sure initiatives are managed appropriately to avoid interruption of supply and operational processes are efficient, scalable and responsive to workflow surges throughout the product lifecycle.

    Responsibility and success for this role would be measured by: 
    • Responsible for communication and management of the Supply Plan.
    • Leads the SMART [Schedule, Make, Assess, Release Team] process for product batch release
    • Monitors and recommends actions to improve order fulfillment rates and prevents and/or reduces backorders.
    • Generate and monitory Key Performance Indicator metrics for the GAM and SCM organization.  
    • Improve service levels within operations for the benefit of internal and external customers.
    • Co-Lead the Executive Supply Update communications. 
    • Schedules and leads the bilateral cross functional planning process.
    • Generates supply models to evaluate business decisions and risks.
    • Maintains and manages the central roll up of the supply plan and updates it quarterly, or at each change in commercial demand forecast.
    • Other duties as assigned.  


    Responsibilities:
    • Operational Excellence / Optimization– Manage and improve internal processes and workflows between quality, regulatory, GAM and SCM – including third party logistics
    • GAM and Supply Chain Analytics – Leverage internal/external systems to align workflows and achieve KPIs for inter-departmental processes: Attain and drive improvements to Key Performance Indicators, including forecast accuracy, demand vs. supply, inventory levels, backorder levels, demand plan (S&OP forecast) vs. operation plan vs. financial plan
    • Manage and monitor CMO batch release timing and review process through SMART team meetings
    • Schedule and consolidate slides for the routine Executive supply updates
    • Miscellaneous special projects that support and impact Supply Chain
    • Create / implement and lead/facilitate an integrated S&OP [commercial demand plan, production plan and final supply plan]


    Qualifications / Experience:
    • Bachelor’ s degree (Master’ s degree a plus)
    • 10 plus years in Pharmaceutical Manufacturing [Sterile Production preferred]
    • Experience controlling and improving Supply Chain costs and service
    • Pharmaceutical technology transfer or product maintenance experience [Sterile products preferred]
    • Experience working with National Accounts, Sales and Customer Service groups
    • Project management and/or process oriented work
    • Six Sigma/Lean a plus
    • Level of Managerial Experience (People) Required
    • Travel 10%
    • Decision Making: Decisions have significant, broad implications for the management and operations of a division. Job contributes to decisions on the overall strategy and direction of the company.
    • Experience working with pharmaceutical manufacturing international supply chains.
    • Contract manufacturing and in-house manufacturing
    • Understanding of supply chain flow from manufacturer through end customer sales [preferred]
    • Strong knowledge of FDA guidance and quality system requirements
    • Strong computer and organizational skills [experience with MS Project strongly preferred]
    • Strong knowledge of supply chain systems and concepts (MRP, Capacity Modeling etc.)
    • Strong project management skills with technology transfer experience of pharmaceutical products [preferred]
    • Understanding of cost and service drivers in operations, manufacturing and distribution
    • Leadership skills and experience working in multi-national teams
    • S & OP process
    • Excellent communication/presentation skills
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Manager, Quality Systems]]> Our client is seeking a Manager, Quality Systems who is a creative, resourceful, integrative thinker for an important role that is responsible for managing systems related to GxP compliance.

    Roles and Responsibilities:
    • Plan, support, and manage Product Complaints as well as other Quality Systems (e.g. Deviations, Investigations, CAPAs, Change Controls, Internal Audits).
    • Assess compliance risk areas (internal and external) and develop and implement risk mitigation measures.
    • Assist and provide guidance for regulatory inspection readiness activities.
    • Ensure compliance with company' s procedures and regulatory requirements.
    • Conduct QA reviews of Deviations, Investigations, CAPAs, Change Controls, Internal Audits, and Product Complaints.
    • Facilitate training of functional areas and develop appropriate training for personnel involved in the execution of Quality System processes.
    • Facilitate and participate in audits of GxP contract service providers.
    • Provide guidance, interpretation and information on GxP regulations, standards and quality systems to functional areas
    • Develop and implement standards, policies and procedures for GxP regulatory compliance.
    • Develop and measure quality metrics to drive consistent quality standards relating to Quality System activities. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
    • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
    • Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.


    Experience, Education and Specialized Knowledge and Skills:
    • Bachelor’ s degree with 5+ years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems.
    • Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
    • Extensive experience in managing.
    • Understanding and application of domestic and international regulatory requirements.
    • Outstanding communication skills (interpersonal, verbal and written).
    • Proven track record of industry success.
    • Strong leadership and management skills; experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
    • Strong team player that has a customer service approach and is solution oriented.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication skills.
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Safety Physician]]> Supports the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies.

    Responsibilities:
    • Provide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.
    • Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
    • May participate in the case narrative generation, review and refinement process depending upon level of experience.
    • Conducts several rounds of query and response (back to site) to gain complete and accurate case information.
    • Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
    • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
    • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
    • High Comfort Level in working in Multidisciplinary teams; providing input in team meetings and relaying information to PV management.
    • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
    • Contribute to preparation and review of periodic reports (DSUR, CSR)
    • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
    • Participate in departmental development activities including Training Staff, SOP and Work Instructions development.
    • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
    • Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
    • Participate in Risk Management Strategy
    • Other activities, as needed or as requested by manager.


    Qualifications:
    • MD, DO or equivalent ex-US medical degree
    • A minimum of 3 years Drug Safety/Pharmacovigilance experience in a pre-approval setting
    • Oncology experience required
    • Experience with Oracle’ s Argus Safety Suite or comparable database required
    • Strong familiarity of GCP, ICH and Global regulations
    • Experienced in the evaluation and interpretation of data
    • Ability to multi-task with close attention to detail
    • Strong written and oral communication skills
    • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner
    • Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents
    • Ability to collaborate well with others
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Clinical Study Monitor]]> As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines.

    Responsibilities:
    • Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures.
    • Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
    • Monitor clinical trial progress through a combination of data review and on-site monitoring visits.
    • Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review).
    • Independently coordinate ongoing and upcoming monitoring assignments
    • Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
    • May assist in the development and writing of clinical trial monitoring plans.
    • May provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
    • Participate in regular monitoring team group meetings.
    • May assist with CRA in-house site related responsibilities
    • May participate in Clinical Operations Committees


    Qualifications:
    • Bachelor’ s degree in a related health profession or nursing
    • 2+ years of oncology monitoring experience
    • Knowledge of FDA regulatory requirements, ICH guidelines, GCP, and commonly used study processes
    • Proficient in RDE, CTMS, Excel and MS Word
    • Experience with data listing and patient profile review is a plus.
    • Ability to work effectively in teams as well as independently
    • Strong verbal and written communication skills
    • Ability to prioritize and manage multiple tasks and responsibilities
    • Excellent communication skills, both oral and written
    • May be home or office based depending on location
    • National Travel: Approximately 50 – 60%
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Senior Director, Translational Science]]> Our client is seeking a Senior Director, Translational Science who is creative, resourceful, collaborative, and entrepreneurial neuroscientist to provide strategic leadership within a growing Translational Neuroscience team.

    The Senior Director of Translational Science will be expected to lead a team of translational scientists to design, validate, and execute translational plans for a growing portfolio of programs. In addition, the Director of Translational Science will serve as a key strategic resource for exploratory biology, experimental medicine, and clinical science teams – providing key biological validation by leveraging insight gained from patient-derived functional, genetic, and biochemical biomarkers.

    The ideal candidate will have strong in vivo biology expertise and the ability to integrate across core complementary technical disciplines, e.g., behavior, biochemistry, genomics, systems biology and neurophysiology, and quantitative sciences. Experience with clinical aspects of translational biology and biomarker research is highly desirable.

    Roles and Responsibilities
    • Provides scientific leadership in areas of biomarker development and translational science.
    • Pro-actively designs, plans, and executes all aspects of research strategies; maintains a strong track record of delivering high quality data and strategic insight into program teams.
    • Provides scientific leadership to multiple cross-functional teams (e.g. exploratory biology, clinical sub-teams, experimental medicine),
    • Identifies and establishes partnering plans with leading research groups to leverage external knowledge and capabilities, and effectively contribute to resource allocation plans.
    • Manages and mentors a team of translational scientists to develop, validate, and implement new biomarkers.
    • Develops and manages functional budget.
    • Prepares and communicates lucid scientific reports (written and verbal) to project teams.
    • Drives implementation of a robust biomarker / translational science publication strategy.
    • Key contributor to high-quality, regulatory documents and scientific publications.
    • May function as a Discovery or Early Development program lead.


    Experience, Education and Specialized Knowledge and Skills
    • Ph.D. in neuroscience, biology, pharmacology or a related scientific discipline with at least 10 years of relevant experience.
    • Multidisciplinary in vivo pharmacologist/systems biologist with complementary technical experience, such as electrophysiology, genomics, neurochemistry, and /or neuroanatomy.
    • Substantial knowledge of CNS drug discovery and development with direct leadership experience; expertise a project leader in Discovery is highly desirable.
    • Experience with building and managing high-performing teams.
    • Computational or programming experience with MATLAB, Pipeline Pilot, Spotfire, GraphPad Prism, Origin, and/or other relevant software or platforms is desirable.
    • Experience interacting with external vendors and with outsource models of R & D highly desirable.
    • Ability to effectively work well with others in a highly collaborative, matrixed research environment.
    • Demonstrated ability to successfully influence internal and external cross-functional teams by promoting creative problem solving, clear decision-making and accountability.
    • Excellent scientific and team-directed communication skills required.
    • The successful candidate will be expected to thrive in the fast paced, dynamic, and nimble environment of a rapidly growing company that depends on strong links and collaboration with contract research organization, academia and nonprofit organizations. Candidate should have substantial experience working with drug discovery and development teams in a matrixed environment. Ability to effectively communicate complex data and results to various stakeholders including: clinicians, program team leaders, senior management is a must.
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Senior Clinical Research Associate]]> Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives.

    Responsibilities:
    • Participates in the preparation and/or review of draft protocol and informed consent documents
    • Possesses detailed knowledge of the study protocol and its associated activities and timelines
    • Participates in conference calls, prepares agenda and summaries
    • Coordinates with project team and other study personnel to determine data collection requirements based on protocol and to test electronic case report forms
    • May review and contribute to, and processes project documents and required reports, such as study protocol documents and consent forms, SAE and protocol deviation reports, accrual and other study status and/or study site reports
    • Contributes to project-specific site initiation activities, tracks readiness status of sites for study initiation, (e.g., submission of essential documents, writes and distributes corresponding internal reports)
    • May conduct site assessments, including site activation, interim monitoring and close-out visits. Writes and distributes site visit reports within established timelines, and tracks resolution of outstanding issues
    • Supports Senior Monitors in the collection, review and maintenance of regulatory documents.
    • Review includes assessment of completeness and compliance with regulatory requirements
    • Prepares and reviews study and project materials, (e.g., Standard Operating Procedures (SOPs), Safety, Monitoring and Issue Escalation Plans, Laboratory Manuals, Data Management User' s Guides, and Study Tools
    • Reviews data listings for inconstant or missing data
    • Generates queries, produces and distributes exception reports and resolves data discrepancies
    • Coordinates with the project statistician or CRO to develop and produce project-specific reports
    • Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs
    • Maintains documentation required by corporate and project SOPs
    • Prepares and may conduct training sessions for site personnel on GCP, study protocol requirements, data systems and data management practices
    • May participate in internal audits and other project and corporate quality assurance activities
    • Reviews and contributes to project-required reports (e.g., MS Project Gantt and Timeline reports)
    • Attends and participates in project and functional area meetings and continuing education
    • Communicates and coordinates effectively with internal and external clients and colleagues
    • May be assigned to special assignments as determined by the Department Head and/or Supervisor


    Qualifications:
    • Bachelor’ s degree in life sciences or Nursing
    • Minimum 6+ years’ in-house oncology experience, phases 1, 2 and/or 3; must also have field experience.
    • Knowledge of FDA regulatory requirements, ICH guidelines and commonly-used concepts, practices and procedures within Clinical Development
    • Proficient in RDE, CTMS, Excel and MS Word
    • Excellent communication skills, both oral and written
    • Ability to prioritize multiple tasks and responsibilities
    • Must be available for up to 20% to 30% national travel
    • Proficient in Spanish or Chinese is a plus
    ]]>
    Tue, 31 Jul 2018 00:00:00 EDT 0
    <![CDATA[Associate Director, Medical Communications and Operations]]>
    Job Responsibilities:
    • Execute, manage, and track strategic medical communications information plans
    • Launch and manage medical information functional operations
    • Represent medical communication and information function at internal meetings, congresses, and with vendors, collaborating closely as needed
    • Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information; act as a resource to others external to Medical Affairs
    • Identify, collect, and provide relevant information and input into business activities such as product and competitor insights, medical product plan and deliverables, new business assessments and other requests
    • Serve as authoritative source of medical/ scientific expertise
    • Ensure compliance with company policies and procedures
    • Perform other duties as directed

    Qualifications/ Requirements:
    • Advanced scientific degree preferred (PhD, PharmD, APRN) with minimum 5 years of experience within a communications function; oncology experience required
    • Excellent project management required; scientific writing skills experiences preferred
    • Ability to lead initiatives and work with teams cross functionally
    • Knowledge of pharmaceutical industry regulations, guidelines, standards and practices
    • Demonstrated problem solving skills in a matrixed environment and in complex situations
    • Personal Characteristics
    • Hands-on with an attention to details, pro-active with internal stakeholders, and leadership skills complemented by sound business acumen
    • Ability to work in a fast-paced environment with competing priorities
    • Takes initiative and works independently and collaboratively with minimal supervision
    • Ability to read, interpret, and convey complex scientific information
    • Excellent written and verbal communication with customer service mindset
    • Ability to work collaboratively towards a common goal
    • Demonstrated results orientation and problem solving skills
    • Travel requirements: up to 10%
    ]]>
    Mon, 30 Jul 2018 00:00:00 EDT 0
    <![CDATA[Clinical Support Specialist ]]> Our client - a global  educational association headquartered in Chicago - is looking to add a Clinical Support Specialist to their team on a permanent basis.

    Job Responsibilities include:
    • Provide  expert clinical support to both clinical and non-clinical surgical clinical reviewers (SCRs) via email and phone on clinical issues, data definitions and the registry.
    • In conjunction with other members of the clinical team, provide initial and on-going training to Surgical Reviewers; manage the  Reviewer certification program.
    • Serve  as an educational resource for internal and external  audiences; act  as a liaison to committees and outside vendors/consultants.
    • Identify streamlining and process improvement opportunities to increase the effectiveness and efficiency of the program and also improve the workflow and satisfaction of Reviewers  in the field.
    • In conjunction with other  staff and leadership, responsible for the successful launch and implementation of new initiatives and programs.
    • Collaborate  with other clinical team members on the writing, editing, implementation, and management of all clinical educational content.
    Job Requirements Include:
    • Registered Nurse with Bachelors in Nursing (BSN) or equivalent. Master’ s degree in Nursing or related field is desired.
    • Two to four years of experience working as a Registered Nurse required.
    • Current RN licensure required.
    • Demonstrated experience, efficiency, and have basic knowledge/understanding of the principles surrounding performance improvement, patient safety, and quality of care, database data entry and/or management, and statistical knowledge.
    • Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, and PowerPoint) and Internet skills. Advanced computer skills helpful.
    • Excellent communication skills (verbal and written).
    ]]>
    Tue, 24 Jul 2018 00:00:00 EDT 0
    <![CDATA[Talent Acquisition Specialist]]> The  Talent Acquisition Specialist  will be  responsible for managing, planning, administering and coordinating multiple complex recruiting functions and providing a wide range of quality Human Resources services to all levels of employees throughout the company.  

    Job Responsibilities:
    • Primary responsibilities relate to implementing aggressive recruiting campaigns for exempt and non-exempt positions
    • Administering the onboarding experience for new  hires at all levels

    Job Requirements:  
    • BA/BS
    • Minimum of 5 years of related human resources generalist experience, including minimum of 2+ years of exempt staff recruiting.
    • Experience using an HRIS system (i.e., UltiPro) and TAMS (i.e., Taleo, UltiPro).
    • Proficiency with use of calendaring software, preferably MS Outlook to manage complex scheduling.
    • Excellent communication, time management, project management, team player, decision-making, organizational, and problem solving skills.
    • Demonstrated flexibility  to multi-task and work autonomously in a fast-paced environment;  high degree of integrity and ability to work with confidential information; collaborative yet able to step into an effective leadership role as needed.
    • Must be able to  embrace change and keep abreast of best practices.
    • Flexibility to infrequently work early evenings or early mornings as interviews or leave issues might require.
    • Proficiency in Microsoft Office (Word, Excel & PowerPoint).
    ]]>
    Mon, 23 Jul 2018 00:00:00 EDT 0
    <![CDATA[Director of E-Commerce]]> The Director, E-Commerce role is a highly visible position that is responsible for creation of the go to market e-commerce strategy, plan development and oversight of its implementation within the Americas (North and South) Operating Unit.   


    JOB RESPONSIBILITIES:
    • Develop an integrated implementation strategy and plan for e-commerce to achieve aggressive sales growth.
    • Lead a team focused on utilizing direct and indirect cross functional resources to drive transformational change leading to the evolution of plans that drive towards the strategic company objective around consumer/customer centricity.
    • Identify organic business opportunities as well as strategic partnerships for growth and expansion.
    • Establish best-in-class partnerships with customers to grow online sales.
    • Develop and influence the organizational design of the e-commerce team.
    • Work across departments to develop a cohesive, encompassing brand strategy and communication plans. 
    • Drive creative thinking and tactical execution across the internal teams.
    • Provide strong inspiration and leadership for e-commerce department and develop skills and team effectiveness.
    • Work in partnership with internal teams and departments to develop a cohesive brand strategy, digital approach and communication plan to bring the e-commerce strategy to life.

    Qualifications/Requirements:
    • BA/BS required; MBA preferred
    • 15+ years of general management experience, combined with hands-on sales experience
    • 5+ years of experience working in or with digital/e-commerce, preferably with a CPG or retail company
    • Previous experience in a consumer product, e-commerce focused role
    • Ability to influence and effectively work cross functionally to implement strategies
    • Must have business plan development proficiency and experience managing a P&L
    • Demonstrated experience meeting and exceeding sales goals and managing top and bottom line growth
    • Strong experience with how products are sold online and distributed in a complex supply chain and understand how to optimize the process
    • Sales leadership, working top to top with large customers, is required
    • Ability to develop a comprehensive strategy routed in the digital path to purchase
    • Experience designing and/or evolving an e-commerce strategy and implementing a plan
    • Experience influencing senior management and developing and sustaining effective relationships
    • Proven experience developing, inspiring and leading teams to deliver superior results
    • Entrepreneurial/visionary; ideal candidate will be passionate about growing a new, strategic business
    • Must be able to think broadly about data and how to effectively use it to drive our e-commerce growth strategy (3 and 5 year strategic plan)  
    • Change agent that can adapt and be flexible to rapidly changing market forces, must be comfortable working in a matrixed organization and confident in leading a team through ambiguity and change
    • Team player with a highly collaborative mindset
    • Must be able to travel, both domestically and internationally
    ]]>
    Thu, 19 Jul 2018 00:00:00 EDT 0
    <![CDATA[Inside Sales Representatives]]> Our client, a leader in metals distribution and fabrication, is currently seeking Inside Sales Representatives to join their customer service center sales team in Minneapolis, MN. Under the supervision of the Inside Sales Manager, the  primary role as an Inside Sales Representative is to provide sales support across company-wide markets in order to achieve sales growth. You will  provide  excellent service while interacting with customers over the phone and through email. Inside Sales Representatives are responsible for direct sales aimed toward growing the  business overall.  

    Job Responsibilities:

    • Collaborates  with a variety of industries while promoting transactional and fabrication sales business
    • Builds professional relationships with customers across multiple geographic markets
    • Responds to customer quotation requests, needs, inquiries, and complaints/concerns
    • Generates sales through focused, pro-active marketing; primarily out-reaching
    • Processes customer orders (i.e. quotations and order entry)
    • Sources for items that are not stocked
    • Identifies strategies to improve/grow sales
    • Understands and incorporates the goals and concepts of our business to grow sales and profitability
    • Works closely with territory managers, credit, inventory, warehouse operations, and other departments within the company
    • Performs other duties as assigned

      Requirements:

    • Associates Degree and 1-3 years of sales or industry experience
    • Previous sales or customer service experience preferred
    • Proficiency with Microsoft applications (i.e., Word, Excel)
    • Attention to detail
    • Ability to skillfully multi-task
    • Results-focused, competitive, and self-motivated attitude
    • Problem solving/conflict resolution and negotiation skills
    • High level of numerical and mechanical aptitude
    • Takes ownership of work; understands the importance of creating value/recognizes opportunities
    • Ability to work well and excel while working with a team or individually
    • Strong interpersonal, written and verbal communication skills

     
    ]]>
    Mon, 09 Apr 2018 00:00:00 EDT 0
    <![CDATA[Associate Director/Director Regulatory Affairs, CMC]]> Our client is looking for an Associate Director/Director Regulatory Affairs, CMC. They will lead the CMC regulatory strategy and processes for assigned programs to significantly contribute in driving the development of our assets forward.

    Job  Responsibilities:
    • Acting as the primary CMC regulatory representative on selected programs to develop CMC regulatory strategies, submissions and compliance activities
    • Managing CMC regulatory activities and timelines
    • Developing the strategy for meetings with regulatory authorities addressing necessary CMC requirements
    • Leading the planning and preparation of the CMC sections of global regulatory submissions
    • Collaborating with the greater CMC teams to provide regulatory guidance
    • Developing and maintaining regulatory knowledge of US, EU and ROW regulations
    • Performing literature searches, preparing special reports and assembling documentation to support project teams
    • Assisting in the development and maintenance of departmental processes, policies, SOPs and associated documents
    • Participating in initiatives aimed at improving internal departmental standards and systems


    Qualifications/ Requirements:
    • Minimum of 8 years of experience in a biotech and/or pharmaceutical environment, including 4-5 years of Regulatory CMC experience
    • Minimum requirement of a Bachelor’ s Degree in a scientific discipline or equivalent
    • Experience with biologics program from development through registration
    • Experience in interacting and meeting with regulatory agency personnel on CMC related topics (e.g FDA, EMA etc.)
    • Experience in compiling and reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.)
    • Knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
    • You must be a team player that can handle multiple tasks simultaneously in a fast growing company
    • Possess outstanding verbal and written communication skills
    ]]>
    Wed, 21 Mar 2018 00:00:00 EDT 0
    <![CDATA[Manager, Medical Information]]> Our client is seeking a Manager, Medical Information who will report to the Associate Director, Medical Information.

    Job  Responsibilities:
    • Supports day to day operations of Medical Information Services function
    • Responsible for the Creation and maintenance of MI documents and ensures that information is scientifically accurate, timely, balanced, and meet customers’ needs
    • Manages medical information responses and materials through the internal medical, legal and regulatory review process  
    • Responsible for tracking responses to medical information requests from internal and external customers through the MI Response Center vendor 
    • Responsible for ensuring that the documentation of the MI inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
    • Monitors adverse events and product quality complaints and processes in accordance with company SOPs
    • Assists in the creation of metric reports on key business processes to monitor Medical Information services
    • Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
    • Perform critical analysis and synthesis of internal/external literature related to products and therapeutic areas of focus
    • Exhibits broad knowledge of assigned therapeutic areas, product labelling and regulatory guidance
    • Serves as Medical Affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into departmental documents and processes. 


    Qualifications/ Requirements:
    • Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD or other advanced degree
    • Minimum of 2 years Medical Information experience with 5+ years in the pharmaceutical/ biotechnology industry
    • Understanding of and adherence to regulatory policies governing scientific interactions with physicians
    • Experience working with vendors on a day-to-day basis
    • Experience with data management and informatics;
    • Excellent written and oral communication skills;
    • Prior industry experience in a post-marketing setting
    • U.S. Launch experience; Orphan, CNS, and / or acute care preferred
    • Ability to quickly understand and communicate all clinical data / publications to support business objectives
    • An outstanding track record of strong communication, presentation, analytic and strategic capabilities
    • This position requires US and international travel, approximately 10 – 25%
    ]]>
    Tue, 20 Mar 2018 00:00:00 EDT 0