<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![CDATA[Associate Director, Quality Assurance (GCP/ GLP)]]> Our client is seeking an Associate Director, Quality Assurance (GCP/GLP). This person will be a creative, resourceful, integrative thinker for an important role that is responsible for GLP and GCP compliance and audit activities.

Job  Responsibilities:
  • Plan and lead GCP and GLP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
  • Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures.
  • Ensure compliance with company' s procedures and regulatory requirements.
  • Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
  • Review and provide input into non-clinical documentation (e.g. protocols, study reports).
  • Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
  • Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.
  • Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems.
  • Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance.
  • Develop and measure quality metrics to drive consistent quality standards relating to GCP and GLP activities.


Qualifications/  Requirements:
  • Bachelor’ s degree with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP and GLP.
  • 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 auditing clinical CRO’ s, clinical sites and investigator sites.
  • Understanding of domestic and international regulatory requirements.
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Thu, 19 Apr 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%
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Thu, 19 Apr 2018 00:00:00 EDT 0
<![CDATA[Senior Clinical Scientist/Associate Director of Clinical Sciences]]> Our client is seeking a talented and passionate individual to join our dynamic clinical team. In this role, you will be responsible for providing scientific support for clinical development activities for drug products in pulmonary diseases. Reporting to the Senior Director of Clinical Science, you will collaborate closely with the pulmonary Medical Director, clinical pharmacology, program management, clinical operations, biostatistics, and data management groups. This cross-functional role includes assembling, evaluating, and presenting scientific and medical data, assisting with writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature. Responsibilities will also include biomarker analysis, data review and trial startup activities for future studies.

You will contribute to the creation and maintenance of a clinical development plan leading to critical decision points for new indications in the development of client drug and other potential drug candidates in pulmonary disease. Applying your strong scientific background with a focus in pulmonary disease and translational medicine, you will clearly communicate concepts and information both in writing and via formal presentations to scientific and medical experts both internally and externally. Someone who can think creatively, function independently, has good strategic insights and knowledge of the activities and procedures involved in clinical drug development and translational science, while having fun along the way, would be a great fit for our group!

Job Responsibilities:

  • Collaborating with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting

  • Providing scientific input to protocol development and helping define efficacy and safety endpoints for all pulmonary studies

  • Preparing data and contributing to scientific publications including posters, abstracts and manuscripts

  • Working as part of an integrated drug development team, you will contribute to the clinical strategy and creation of the clinical development plans for pulmonary indications for one or more drugs

  • Providing scientific input to the preclinical pharmacology team for translational studies of interest including biomarker development strategies

  • Supporting the Medical Monitor with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals

  • Participating in the identification of appropriate external investigators and consultants

  • Developing and cultivating relationships with external partners such as clinical investigators, clinicians, scientists, and vendors

  • Providing support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations

  • Understanding competitive landscape and providing insights on strategic development pathways

  • Proactively seeking out and recommending process improvements

  • Anticipating potential study problems and preparing contingency plans as needed

  • Communicating clearly and precisely with all levels of the company globally


Qualifications/ Requirements:

  • MD, PhD or PharmD, or equivalent with clinical research experience

  • At least 2-5 years of technical/operational experience in planning, executing, reporting and publishing clinical studies

  • Strong scientific background, with clinical and/or research experience in pulmonary disease (e.g. pulmonary arterial hypertension)

  • Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 2 and 3 clinical studies

  • Familiarity with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements

  • Strong analytical and strategic thinking skills

  • Experience interacting with clinical investigators and medical experts

  • Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required)

  • Willingness to travel up to 10%
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Thu, 19 Apr 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Regulatory Affairs]]> Responsibilities
  • Develop regulatory strategy and submission plans for quality and timely filings.
  • Provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
  • Oversee preparation, review, and submission of regulatory documents maintaining compliance with regulatory requirements.
  • Prepare regulatory agency meeting requests and briefing documents.
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Support the organization and record regulatory meetings with health authorities.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
  • Provide support for regulatory review of publications and clinical trial materials
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.
  • Assist with SOP generation.
  • Perform other duties as required, interfacing with other departments, CROs and external vendors as needed


Experience, Education and Specialized Knowledge and Skills
  • At least 8+ years of experience in Regulatory Affairs related development of pharmaceuticals; preference for experience with small molecule development (Phase 1 through NDA and post-approval)
  • Bachelor of Science in a scientific discipline, Masters preferred
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.
  • Strong regulatory writing skills and knowledge of eCTD elements and structure
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Thu, 19 Apr 2018 00:00:00 EDT 0
<![CDATA[Senior Director, Regulatory Affairs]]> Our client is seeking a Sr. Director, Regulatory Affairs. As a member of the program teams, they will provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.

Responsibilities
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Organize and manage regulatory meetings with health authorities.
  • Review materials for compliance with advertising and promotion regulations.
  • Perform regulatory strategic assessments for new product candidates and new indications.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.


Requirements:
  • 10-15 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
  • Bachelor of Science in a scientific discipline, MS or PhD preferred
  • Strong knowledge of eCTD elements and structure
  • Strong regulatory writing skills and use of Microsoft Word
  • 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.

 

 
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Thu, 19 Apr 2018 00:00:00 EDT 0
<![CDATA[Manager, Medical Affairs Operations ]]> Our client is looking for a self-motivated team member for a role that is responsible for the project management and facilitation of multiple medical affairs initiatives. This position will function under the guidance and direction of the Director, Global Medical Affairs Operations.

The successful candidate will have experience managing several projects simultaneously in a fast-paced environment that is deadline driven. This role will require extensive cross-functional collaboration (including all Medical Affairs functions, Finance, IT, Legal, and Commercial) and the ability to work with and influence stakeholders across all levels. The successful candidate will have experience with and excel in using a range of technical and leadership skills to keep projects on time and to facilitate team meetings.

He/she will also be responsible for identifying, triaging and supporting the creation and implementation of department best practices and core capabilities to support the continued growth and development of the department.

Responsibilities:
  • Provide project management for key medical activities and strategic initiatives.
  • Utilize PM technologies and methodologies to keep projects on track and to provide visualizations of plans, timelines and status for relevant projects
  • Regularly meet with stakeholders for project updates; develop risk mitigation plans as necessary
  • Provide stellar meeting management and facilitation to ensure projects and plans move forward
  • Support development of best practices, SOPs, system capabilities for Medical Affairs
  • Work closely with finance and Medical Affairs functional leads to provide oversight of medical affairs spend against the annual operating plan budget.
  • Work closely with legal and contracting to facilitate timely processing of high priority contracts; initiate process efficiencies when appropriate
  • Support efforts to continually improve business practice processes and tools to achieve medical operational excellence
  • Serve as mentor to other team members


Requirements:
  • 5+ years of Pharmaceutical/Medical Affairs Operations experience is highly preferred
  • 5+ years of Project Management experience
  • Expert knowledge of MS Project, PowerPoint, and Excel
  • Working knowledge of Visio/Lucidchart, Think-Cell preferred
  • Must be able to actively manage and track many complex projects in parallel, managing the actions of many people toward shared outcomes.
  • Must possess excellent communication skills, relationship building capabilities, and proven ability to influence decision-making without authority.
  • Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in a rapidly growing and changing environment.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
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Thu, 19 Apr 2018 00:00:00 EDT 0
<![CDATA[Director, Program/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.
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Thu, 19 Apr 2018 00:00:00 EDT 0
<![CDATA[Sr. Clinical Trial Manager]]> The Sr. Clinical Trial Manager (CTM) is responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase 1-3; or multiple smaller early-phase studies. The Sr. CTM is expected to provide leadership within the department and guidance with regards to the operational aspects of executing clinical development deliverables. This position reports to the Director, Clinical Operations.


Primary Responsibilities Include:
  • Clinical Trial Management:
    • Serve as the clinical point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trial and program.
    • Lead and coordinate clinical study management meetings
    • Responsible for oversight and project management of individual studies as well as relevant program related activities.
    • Train team members and site staff, including vendors, as needed
    • Drive traceability procedures for investigational products and cross functionally coordinate patient treatment planning
    • Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, and motivational visits, as needed
    • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
    • Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
    • Assist in preparation and review of clinical documentation such as informed consent, clinical protocols, Investigator Brochure, Clinical Monitoring Plan, study manuals, study tools, etc.
    • Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.
    • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
    • Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
  • Fiscal and Contracts Management:
    • Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
    • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
    • Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.
    • Responsible for creation and management of program-level budget(s) with Program Lead.
    • Participate in contract and budget negotiations with CROs, clinical sites and vendors
  • Cross Functional Mentoring and Leadership:
    • Work cross-functionally to ensure clinical program timelines and goals are met.
    • Provide study-specific mentoring and line management for junior team members, as appropriate.
    • Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.).

 

Education and Skills Requirements:
  • Bachelor’ s degree in health sciences or related field.
  • Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management.
  • 1-3+ years of clinical study management experience with global clinical studies.
  • Experience in management of CROs, vendors and consultants.
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
  • Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and program-level budgets, site selection and clinical supplies management.
  • Proficient written and verbal communication skills.
  • Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
  • Position may require some travel.
  • Attributes:
    • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
    • Ability to function at a high level in a team setting
    • Proactive and positive management approach
    • Maximum flexibility to adapt to changing program needs in real time
    • Strong leadership skills
    • Ability to build strong relationships with co-workers of various backgrounds and expertise
    • Recognized by former peers, colleagues, managers and direct reports for attributes congruent with CPI FIRST Values: Focus, Integrity, Respect, Science, Teaching
    • Excitement about the vision and mission of CPI

 
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Thu, 19 Apr 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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Wed, 18 Apr 2018 00:00:00 EDT 0
<![CDATA[Manager/Sr. Manager, Clinical Operations]]> Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities

Works to ensure adherence to a standardized approach to project management

Manages clinical trials projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of an Associate Director, Program Lead.  May rely upon Senior Clinical Project Managers for guidance but acts as a mentor/coach to junior staff.

Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters

 

Responsibilities:

 
  • Develops a quality control plan for trial master files and then ensures those TMFs are created, maintained, monitored, and closed out on a timely basis
  • Ensures site monitoring reports are accurate and thorough and that metrics are being adhered to
  • Actively participates in the development of department initiatives, including acting as lead on the development /definition of certain SOPs and processes
  • Ensures that an overarching trial cross-functional quality plan is in place
  • Responsible for managing creation, maintenance and close out of TMF activities – e.g. manages Central Lab and ancillary vendors such as IVRS selection, set-up, conduct, and close-out for studies.
  • Oversees and manages vendors (CRO) to ensure that clinical trials are getting the necessary resources and attention the vendor has committed to ensure trial deliverables and performance goals are met.
  • Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, PDT, and FAHs are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs; works with RA to establish timeframes and ensure clarity of documentation required; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
  • Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, and data collection) with other functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Provides regular timely communications to Supply Operations regarding patient enrollment information at sites to support the supply of drug products to patients
  • Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
  • Adheres to clinical trial budgeting process and provides input on process optimization landscape
  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close to ensure both internal and external deliverables are on time and on budget
  • Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
  • Proactively identifies, negotiates and brokers solutions to individual clinical study issues
  • Delegates and oversees the management of certain aspects of project management to CTA and Senior CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.

Requirements
  • BA/BS with 5-7 years progressive experience in clinical operations preferably within the biotech, pharmaceutical, CRO, industry
  • Demonstrates ability to provide input into clinical protocol development.
  • Demonstrates ability to manage and execute clinical studies.
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Experience of managing/overseeing CROs/vendors.
  • As a result of being member and project manager of CST, develops detailed understanding of different departments and functions and interdependencies of the functions.
  • Very strong verbal, written and presentation skills are required.
  • Experience of leading of a matrixed cross-functional team.

 
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Wed, 18 Apr 2018 00:00:00 EDT 0
<![CDATA[Associate Director Clinical Quality Assurance ]]> The Associate Director Clinical Quality Assurance will conduct audits of external providers including CROs, vendors and clinical trial sites along with internal documentation, system and process audits. The Associate Director is also responsible for the initiation, conduct, and follow-up of audits as assigned. This position reports to the Sr. Director Clinical Quality Assurance.

Job Responsibilities:
  • Development of Master Audit Plan for Clinical and Nonclinical (GLP)
  • Ensure that the audit plan is implemented, in order to provide assurances that clinical and nonclinical studies are of the highest quality standard and are in compliance with the requirements of company SOPs, study protocols, relevant regulations (GXPs) and ICH guidelines / GCP and GLP regulations
  • Ensure that audit results are formally and consistently recorded, reported, monitor trending and also ensure that corrective/preventive actions have been requested and documented effectively
  • Managing vendors and CROs during external and internal auditing
  • Development, training and maintenance of Clinical SOPs and Training Plan
  • Document QC (Trial Master Files, CSRs, Protocols, submission documents etc.
  • ICH/GCP Training at investigator meetings and internally
  • Assist in BIMO and Inspection Readiness Activities
  • Manage Audit Consultants and Internal Auditors


Requirements:
  • Qualified candidate must possess a bachelor' s degree in Science, or equivalent degree/experience
  • Demonstrated experience with SOP and or GCP Training
  • Demonstrated experience conducting GCP audits and/or hosting regulatory authority inspections
  • Strong GCP knowledge and experience with 5-8 years of direct GCP experience working in a pharmaceutical or biotechnology firm and or with a CRO is required
  • Previous GMP or GLP experience preferred but not required
  • In depth knowledge and understanding of drug development and the clinical trial process
  • In depth knowledge of current regulatory requirements and experience with global regulations and guidelines
  • Experience in developing and implementing Quality Management Systems
  • Team building and leadership skills
  • Strong written and oral communication skills
  • Computer/technical skills
  • Other position-related skills (i.e. project management skills, team collaboration, detail-orientation, management skills, other soft skills, etc.)
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Wed, 18 Apr 2018 00:00:00 EDT 0
<![CDATA[Sr. Associate, Regulatory Operations]]> Our client is seeking a Sr. Associate, Regulatory Operations to be an integral part of the day to day publishing efforts, coordinating with internal team members and external vendors. Help to implement a content management system for the use of the entire company for authoring and approval of applications.

Responsibilities:
  • Electronically publish regulatory submission documents to industry and company defined standards (INDs, CTA, MAA, BLAs, eCTD, NeES, etc.)
  • Coordinate with vendors to support Regulatory submissions goals
  • Partner with regulatory team members as well as members of the Project Management, Commercial, Clinical, Medical Affairs, Clinical Operations, Nonclinical, CMC and Quality functions to ensure strong, clear communication and to identify and address challenging issues in the management of content for regulatory submissions. The primary focus will be on major marketing and clinical applications in order to achieve regulatory goals.
  • Electronically publish regulatory submissions using the eCTD software suite to industry and company defined standards
  • Adhere to assigned timelines for global regulatory submissions
  • Provide business user support for the workflow of regulatory submission documents through the document management system
  • Execute assigned activities for eCTD life-cycle document management within the document management system and the eCTD software suite
  • Execute and adhere to Regulatory Operations work practices and guidelines, as well as author new processes as required
  • Maintain the eCTD word processing templates and train users on their functionality


Requirements:
  • BA/BS degree and 2-5 years in the pharmaceutical industry Regulatory Operations arena is required
  • 2-5 years of hands on experience with an eCTD Software System is preferred
  • 2-5 years of advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required
  • 2-5 year of user experience within an enterprise Document Management System is required
  • Knowledge of the industry standards for desktop publishing regulatory submission documents
  • Experience on a cross-disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is desired
  • Experience with Microsoft Excel and Microsoft Project is desired
  • 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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Wed, 18 Apr 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Medical Publications and Communications]]> Our client is seeking an Associate Director, Medical Publications and Communications. The successful candidate will be responsible for interacting with various investigators, HCPs, vendors, and internal departments to lead publications planning and management for assigned therapeutic area(s) while ensuring compliance with good publication practices and scientific merit of medical publications.

Job  Responsibilities:
  • Work with internal and external authors in actively facilitating the development of abstracts, posters, presentations, original manuscripts, and review papers.
  • Lead cross functional strategic publications efforts in alignment with product development teams to ensure prioritized submission and publication of data to address unmet educational needs.
  • Coordinate medical writing and external vendor activity to ensure timely delivery and submission of publications.
  • Ensure consistent adherence to established  publication process in accordance with good publication practices.
  • Manage assigned publications spend to ensure accurate accounting and reconciliation to available budget.
  • Collaborate with functions inside and outside of Medical Affairs to translate available data and publications into medical communications and educational resources.
  • Partner with Congress Strategy lead and conference planning team to map out oral and poster presentations.
  • Cover poster and scientific sessions at select medical conferences and write debriefs.


Qualifications/ Requirements:
  • This position requires a clinical and scientific background and significant biotechnology/pharmaceutical industry experience in leading publications efforts in a highly matrixed organization.
  • 8+ years in a biotechnology/pharmaceutical environment required. Has attention to detail, excellent communication and project management skills, and proven ability to effectively collaborate and influence decision-making across multiple levels of an organization, including senior leadership.
  • Willing and able to travel for medical conferences as necessary.
]]>
Tue, 17 Apr 2018 00:00:00 EDT 0
<![CDATA[Clinical Research Associate - Midwest]]> The Clinical Research Associate (CRA) is responsible for conducting monitoring activities at a clinical site (s).

Job Responsibilities:
  • Follow all appropriate Standard Operating Procedures (SOPs)
  • Travel to research sites as needed
  • Attend client-specific training to successfully execute assigned responsibilities
  • Create materials as needed to successfully execute assigned responsibilities
  • Perform source data verification, review regulatory documents and test article, assess protocol and regulatory compliance, and prepare trip reports as outlined in the Monitoring Plan
  • Perform other duties as requested by management.


Qualifications/ Requirements:
  • Bachelor’ s Degree in a scientific or healthcare discipline. A licensed RN may be considered.
  • 1 – 3 years of monitoring experience in multiple therapeutic areas.
  • Ability to travel nationally up to 80% (average)
  • Industry certification preferred
  • Current knowledge of and the ability to apply ICH / GCP and all applicable regulations and guidelines
  • Excellent written and verbal communication skills including superior command of English
  • Proficient computer skills with experience in Microsoft Word, Excel, and PowerPoint
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Tue, 17 Apr 2018 00:00:00 EDT 0
<![CDATA[Senior Clinical Data Manager]]> As a member of our growing Data Management team, you will significantly contribute to the success of the DM function by having a large impact and leading the DM tasks on assigned projects.  You will work with a team-oriented and dedicated group who will welcome your innovative ideas while motivating and challenging you along the way.

This position works with clinical, biostatistics, and contract research organizations (CROs) to ensure that data management activities are performed with quality according to project timelines.  This position will manage all data management activities from CRF design through database lock for in-house and outsourced clinical trials with minimal supervision.

Responsibilities:
  • Independently lead and represent Data Management (DM) for all DM activities of an assigned study or assigned studies within a program 
  • Initiate, facilitate, lead and document all DM project management activities, e.g. DM deliverables, DM meetings, minutes
  • Establish rapport and maintain positive, open communication with internal and third-party teams
  • Mentor, lead and provide DM guidance to junior level DM team members
  • Will delegate DM activities to junior level staff as needed for assigned studies and independently perform ongoing data quality reviews, provide training and direct study team members to ensure data quality
  • Will be the DM subject matter expert for DM process questions from CROs, third party vendors and cross functional areas, e.g. Clinical Operations, Medical, Biostatistics, Programming, PVG, IT
  • Will review upcoming DM deliverables and forecast resourcing requirements as needed to execute ongoing and upcoming DM activities within timeline and budget requirements
  • Participate in reviewing requests for proposals (RFPs) and providing budgetary, contractual and scope of work (SOW) feedback for the DM functional area
  • Able to execute all activities required of the Senior Clinical Data Manager position:
  • Works with clinical, biostatistics, and CROs to design and develop study documents including Case Report Forms (CRFs), CRF Completion Instructions, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format
  • Manages the CROs to ensure that outsourced data management tasks remain on target according to project timelines and within budget
  • Manages third party vendors including review of data transfer specifications, managing data deliverables, reconciliation and ensuring quality transfers on time and within budget
  • Proactively organizes ongoing data review within clinical and biostatistics throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies

Oversee and perform, as necessary, the following tasks:
  • Serve as the primary point of contact for DM functional area
  • Drive study setup, maintenance and lock activities
  • Plan and perform user acceptance testing of clinical database (CRF and edit checks)
  • Generate, review and approve data management plans
  • Review and approve data transfers and other deliverables from external sources
  • Lead cross-functional discussions to define data handling and database design standards
  • Define and manage timelines to meet deliverables on time and with quality
  • Generate and disseminate project status reports to management
  • Manage CRO/data management specific vendor activities, timelines, and budgets
  • Participate in data management initiatives such as evaluate technology vendors (i.e. EDC, analytic tools), author and review SOPs, and establish data collection and reporting standards


Qualifications:
  • Minimum 5 years of experience in CRO, Pharmaceutical or Biotech Clinical Data Management and 2 years as a Lead CDM
  • Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations
  • Experience with Medidata RAVE, SAS and Coding tools
  • Awareness and familiarity of statistical methodology
  • Ability to solve complex problems in all areas of data management
  • Effective communication skills, both verbal and written
  • Strong attention to detail
  • Bachelor’ s degree required 
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Tue, 17 Apr 2018 00:00:00 EDT 0
<![CDATA[Manager, Regulatory Operations]]> The successful candidate will be responsible for the maintenance and support of Regulatory systems used to facilitate the creation of compliant submissions and for the maintenance of Regulatory information. They will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners.

Job  Responsibilities:
  • Maintain and support Regulatory systems such as electronic document management (EDMS), Regulatory Information Management (RIM), and eCTD publishing
  • Manage and oversee the development of training materials specific to Regulatory systems
  • Liaise with internal and external stakeholders to ensure the compliance of deliverables being transmitted to a health authority
  • Represent Regulatory Operations on internal teams to support filing activities
  • Prepare and transmit electronic submissions (paper submissions, when applicable)
  • Interface with external publishing partners on submission compilation


Qualifications/ Requirements: 
  • 5-7 years’ experience working in a Regulatory Operations environment
  • Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software
  • Experience managing EDMS, regulatory publishing systems, and tracking databases
  • Detailed knowledge of clinical and nonclinical data standards (ADaM, SDTM, SEND)
  • Expert knowledge of Microsoft Office and Adobe Suite (MS Project is a plus)
  • Demonstrated experience and a clear understanding of submission content and format requirements
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines
  • Solid experience administering and maintaining Regulatory document authoring templates
  • Strong oral and written communication and interpersonal skills
  • Strong project management and organizational skills
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Fri, 13 Apr 2018 00:00:00 EDT 0
<![CDATA[Contract Trial Master File]]> Job Responsibilities:
  • QC and reconcile available electronic and paper files from one or more Trial Master Files and document deficiencies
  • Create inventory of documents on hand TMFs and identify and document   gap(s)
  • Maintain the TMFs according to applicable   SOPs Provide document tracker or listing for Clinical Trial Monitors to assist in document reconciliation and retrieval from clinical sites
  • Provide the study team updates on TMF status
  • Contact clinical sites as directed to obtain documents
  • Primary point of contact for internal study teams to ensure document quality requirements and timelines are met


Qualifications/ Requirements:
  • Bachelor' s degree or equivalent
  • Clinical documentation management and industry experience of at least 2 years; TMF audit experience a plus
  • Experience/knowledge of ICH/GCP, US 21 CFR, and FDA BIMO   documentation requirements
  • Ability to quickly adapt to systems and technology
  • Ability to travel domestically as needed
  • Willingness to work in-house 5 days/week
  • Position not to exceed 40 hrs./week.
]]>
Fri, 13 Apr 2018 00:00:00 EDT 0
<![CDATA[Medical Reviewer Consultant for MRC and PMRC]]> Our client is seeking an experienced, knowledgeable, detail oriented and resourceful consultant to aid in medical review of a variety of materials for MLR (medical, legal, regulatory) and PMRC (Promotional material review committee) review.

The primary function of the Medical Reviewer will be to serve as the Medical subject matter expert, providing guidance and feedback during review of promotional, scientific and corporate materials. As a member of the promotional and medical review teams, they will have a strong understanding of FDA regulations associated with prescription drug and medical device promotion.

The Medical Reviewer will ensure that advertising and promotional materials align with product labeling, and claims are well substantiated by clinical data and/or published literature. The Medical Reviewer will have a strong scientific background with good understanding of appropriate scientific referencing practices.

Roles and Responsibilities:
  • Member of MLR and PMRC- working with internal stakeholders at the initiation, creation and review of educational and promotional materials
  • Provide medical expertise in review and approval of external resources, communication and publications to ensure medical accuracy, objectivity and fair-balance.
  • Provide medical expertise in support of developing content (slides, websites, standard response letters) for medical communications and education to advance disease state and clinical understanding
  • Key responsibilities will require him/her to interact with other departments including commercial, clinical, safety, legal and regulatory


Experience:
  • PhD, MD, or DO with prior industry experience in psychiatry/mood disorders/postpartum depression
  • Minimum of 5 years of pharmaceutical industry medical review experience
  • Must have authored peer-reviewed scientific publications
  • Must possess excellent communication skills, relationship building capabilities, and proven ability to influence decision-making without authority
  • Is seen as a scientifically credible leader and collaborative partner to internal and external stakeholders
  • Ability to flexibly tailor effective communication to multiple social styles
  • 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.
]]>
Thu, 12 Apr 2018 00:00:00 EDT 0
<![CDATA[Clinical Data Coordinator]]> The Clinical Data Coordinator will be responsible for supporting all data management aspects of clinical trials and will work closely with senior DM personnel, and as assigned, with CROs and other third-party providers of data services.  Activities performed are with the primary goal of ensuring data integrity and ensuring analysis ready data. 

This person will perform a variety of clinical data management supportive activities and procedures for collecting, recording, reporting and maintaining data in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning and task completions.

Job Responsibilities:
  • Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data
  • Contribute toward the administrative management of study data according to study protocol, study plans and SOPs
  • Assist with study data quality checking, query management and resolution for content, accuracy and completeness
  • Participate in completing and verifying specifications and or outputs (ex. listings, reports, metrics, data visualizations, etc.) and performing general quality control verifications for quality issues
  • Understand/follow important study documents such as Data Management Plans (DMP), validation specifications, reconciliation plans, etc.
  • Participate in UAT for build/work of EDC databases, reporting tools and other electronic systems and applications
  • Perform review, maintenance and archiving activities of DM related study documents ex. data transfer plans, electronic case report forms (eCRFs), completion guidelines, etc.
  • Perform reconciliation activities of data from external vendors
  • Managing and creating reports and or metrics to track and report data/query status
  • Contribute toward improved data management standard working practices and process improvement initiatives
  • Attend relevant study meetings and serve as support to the DM personnel and study team
  • Learn multiple EDC platforms, data visualization tools, and related processes, i.e. Rave, Comprehend, Spotfire, etc.


Requirements:
  • BS/MS and 1+ years of relevant work experience in clinical trials or data management in the clinical research sites or pharmaceutical/biotechnology industry
  • Independently motivated, detail oriented and good problem-solving abilities with huge drive to learn and enhance your skills
  • Proficient and willing learner of multiple systems and applications such as EDC platforms, data visualization tools and related processes. 
  • Past experiences and background in relevant industry technologies preferred. Knowledge of database design and database concepts helpful
  • Skilled computer skills including MS office products
  • Knowledge of related regulations, GCP and Good Clinical Data Management Practices
  • Skillful with medical terminology and or labs. Background in oncology & hematology
]]>
Tue, 10 Apr 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

 
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Mon, 09 Apr 2018 00:00:00 EDT 0
<![CDATA[Sr. Clinical Study Manager]]> In this important Clinical Operations leadership role, the Clinical Study Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials.  In addition to exceptional project delivery, we seek strong analytical skill and leadership qualities that will influence our internal team and motivate our CRO partners. The ideal candidate values bringing important medicines to patients in need, and shares our team’ s determined, positive attitude.

Job Responsibilities:

  • Broad view of the departmental goals and sees the “ big picture” scientifically and strategically;

  • Regularly interacts with Clinical Affairs and company leadership on matters concerning clinical development status;

  • Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.

  • Efficient at clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics;

  • Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for one or more clinical trials.

  • Leads by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.

  • Ensures compliance of clinical trials with federal and applicable regulatory agency requirements.

  • Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.

  • Integrates best practices as appropriate.

  • Represents Company in external interactions.


Qualifications/ Requirements:

  • BS/MS in science or a health-related field is preferred;

  • At least 4+ years related work experience, at least 2 years in a study management role.  Biopharmaceutical (Sponsor) organization experience is a must. CRO experience also desirable;

  • Demonstrated effectiveness in resolving study management issues;

  • Experience managing and training regional or consulting CRAs within project teams is required; direct line management is not required;

  • In-depth knowledge of the CRO selection and contracting processes;

  • Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization;

  • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
]]>
Mon, 09 Apr 2018 00:00:00 EDT 0
<![CDATA[Senior Clinical Data Manager]]> The Senior Clinical Data Manager is responsible for the data management aspects of clinical trials and works closely with DM CROs and other third-party providers of data services, Clinical Operations, EDC Developers, Drug Safety, and Data Visualization/Data Repositories. Activities includes all DM aspects of collaborating and or supervising vendors in setting up, managing and completing trial database systems and CRFs through DB lock within timelines with the primary goal of ensuring data integrity and ensuring analysis ready data.

Responsibilities:
  • Lead DM for assigned projects
  • Oversee vendor performance and deliverables
  • Manage assigned DM timelines and ensure deliverables/timelines are met
  • Work with the cross-functional representatives for each study to ensure that the database captures all critical data
  • Direct the coordination, gathering and providing necessary clinical data/reports for internal DMC meetings
  • Provide data management support (directly and/or through vendor management) for ongoing trials:
  • Understand/follow and create Data Management Plans (DMP), validation specifications, etc.
  • Participate in UAT for each database build/work with vendor to understand the impact of any mid-study updates to the EDC database.
  • Review of electronic case report forms (eCRFs) for completeness, content and database considerations
  • Perform data review for quality issues and general data trends
  • Supervise reconciliation activities using data from external vendors
  • Managing and creating reports and or metrics to track and report data/query status
  • Assist in in the development of data management standard working practices.
  • Assist in creating data visualizations, as required, for presentations
  • Participate in data management activities in support of new clinical trials:
  • Serve as DM representative at study team meetings
  • Provide input into study protocols from a data management perspective
  • Participate in eCRF and database design
  • Generation of Data Management deliverables including Data Validation Specifications and CRF Completion Guidelines
  • Work on process improvement initiatives


Qualifications:
  • 7+ years of relevant work experience in clinical data management in the pharmaceutical/biotechnology industry with strong CRO oversight.
  • B.S. or higher
  • Proficient in multiple EDC platforms, related processes and data visualization tools, i.e. Comprehend, Spotfire, etc.
  • Very organized and creative problem solver
  • Strong knowledge of global standards data management standards (CDASH/SDTM)
  • Experience in oncology & hematology studies
  • Knowledge of related regulations, GCP and Good Clinical Data Management Practices
  • Skillful with medical terminology and advanced background in labs
  • Knowledge of database design and database concepts
  • Good understanding of coding (MedDRA, WHO drug dictionaries)
  • Skilled computer skills including MS office products
  • Excellent written, verbal and communication skills
  • Ability to handle multiple projects and be a team player
]]>
Wed, 04 Apr 2018 00:00:00 EDT 0
<![CDATA[Director of New Product Planning ]]> Our client is a Commercial Oncology organization and is seeking a Director of New Product Planning reporting to the VP Commercial Marketing. The Director of New Product Planning will lead the development of the strategic marketing direction of key assets in the current Oncology pipeline and the basket of upcoming Oral Oncology pipeline assets.

Job Responsibilities:

  • Lead the strategic and tactical aspects of pipeline commercialization for Solid Tumor assets in collaboration with the existing U.S. Oncology Teams, Medical Affairs, Regulatory, Research & Development, Managed Health Care, Forecasting, Finance, Business Development and Licensing & Acquisition, and the Global team (primarily Global Commercial Development and Global Marketing & Commercial Operations).

  • Ensure priorities of the commercial Oncology Franchise are embedded and shape the overall strategies for Asset Teams at various stages of development.

  • Serve as the U.S. Commercial point of contact & subject matter expert on matrix teams like the Global Commercial Teams.

  • Build organizational readiness, knowledge base & expertise, and strategic direction of these pipeline assets in new indications.

  • Develop deep commercial insights on competitive landscape, payer/reimbursement requirements, unmet medical needs, and evolving treatment patterns.

  • Co-lead and participate in market research and insights, financial planning, and strategic planning for these pipeline assets.

  • Contribute to the development of internal and/or external communications pertaining to the Oncology pipeline, as appropriate.

  • Partner with all stakeholders to help inform the design of efficient Marketing and Sales organizations, over time.

  • Develop and oversee budget for assigned initiatives.

  • Develop annual commercial plans for each pipeline asset.

  • Manage consultants/agencies for key projects.

  • Build current and future competitive advantage by understanding & addressing key customers’ needs, and by demonstrating deep understanding of competitors’ strategies.

  • Develop internal and external customer relationships that successfully drive business objectives.

  • Ensure timely guidance to senior management regarding the strategy and key brands.

  • Establish a productive work environment by creating trust and respect within the franchise.

  • Balance business priorities and resources, adapting to the external and internal environment.

  • Position requires excellent communication skills and strong analytical skills to understand scientific and financial data, recognize key issues, establish priorities, and prepare high-level presentations for senior executive staff review.

  • Supervisory/Management Responsibilities – could eventually lead a small team.


Qualifications / Requirements:

  • 12-15 years of experience in the pharmaceutical/biotech industry in progressive commercial leadership roles.

  • Oncology experience required, preferably 5+ years of operational experience at a minimum.

  • Leadership experience in a combination of strategic marketing, pipeline marketing, new product planning, launch planning, R&D portfolio strategy, and/or market research/analytics.

  • Must possess strong scientific and clinical understanding of Oncology.

  • Bachelor’ s degree required, advanced degree preferred.

  • U.S. Commercial experience required with strong matrix skills and cultural sensitivity.

  • Demonstrated ability to influence and manage a complex set of internal and external stakeholders.

  • Strong executive presence and leadership skills.

  • Capable of attracting and developing world-class commercial talent.

  • Strong communication and negotiating skills required.

  • Key Leadership Competencies

  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.

  • Learns fast, grasps the “ essence”, and can change course quickly when necessary.

  • Raises the bar and is never satisfied with the status quo.

  • Creates a learning environment, open to suggestions, and experimentation for improvement.

  • Embraces the ideas of others, nurtures innovation, and manages innovation to reality.
]]>
Tue, 03 Apr 2018 00:00:00 EDT 0
<![CDATA[Manager, Clinical Compliance Process]]> Job Responsibilities:
  • Support inspection readiness activities and execute quality control of various documents and files
  • Review and message management of clinical trials email-box, and other central e-mail as assigned
  • Review of the public disclosure tracker for upcoming due dates for registration/results
  • Assisting with generation of disclosure packets for contract public disclosure writers
  • Review regulatory agency websites for pertinent updates
  • Assisting with vendor KPI completion and tracking
  • Assisting with policy, SOP, forms, templates, and plans generation and editing/formatting as assigned
  • Supporting Open Payments and other requirements for financial transparency by gathering and compiling data as assigned
  • Support as needed and assigned other Clinical Compliance projects, initiatives, and requirements


Qualifications/ Requirements:
  • Bachelor’ s Degree, preferably in healthcare or clinical research
  • Strong technical writing skills
  • Ability to work under pressure and maintain flexibility
  • Attention to detail
  • Solid knowledge of applicable regulations and guidance. Knowledge of multiple public disclosure registries (CT.gov, EU CTR, ENCePP, etc.).
  • Proficient with all MS Office applications, SharePoint, Adobe Acrobat
  • Excellent communication skills / flawless spoken and written English, additional language(s) a plus
  • Never disqualified or sanctioned by a regulatory agency
  • Able to provide at least two references and a writing sample
  • Able to travel occasionally if requested
  • Able to lift/ move a full file box on occasion if needed
  • Essential Core Competencies:
    • Action Oriented
    • Problem Solving
    • Organization
    • Functional/Technical Skills
    • Priority Setting
    • Drive for Results
    • Strategic Agility
    • Intellectual Horsepower
    • Dealing with Ambiguity
  • Core Behaviors:
    • Integrity and Trust
    • Composure
    • Standing Alone
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Tue, 27 Mar 2018 00:00:00 EDT 0
<![CDATA[Director, Medical Communications]]> Based in Cambridge Massachusetts and reporting directly to the Executive Director, Global Head Medical Communications and Medical Information. The Director of Medical Communications will be accountable for development and implementation of the global medical communications strategy and establishment of scientific communication platforms for all products both marketed and in development.

Job Responsibilities:

· Lead the cross-functional publication team, align key internal stakeholders on publication plans (e.g. R&D, Medical Affairs, Regulatory) and communicating plans / outputs to relevant stakeholders (e.g. investigators) to ensure prioritized submission and publication of data to address unmet educational needs.
  • Work with internal and external authors in facilitating the development of abstracts, posters, presentations, original manuscripts, and review papers.
  • Contribute to and ensure development of abstracts for submission to all congresses and partner with Congress Strategy lead from Medical and Commercial to map out accepted oral and poster presentations
  • Coordinate and manage the Scientific Medical Writing group to ensure timely delivery and submission of publications.
  • Collaborate with multiple functional teams including Medical Affairs, clinical and R&D to identify available data and publications into medical communications and educational resources.
  • Drive development of scientific communications platforms.
  • Contribute to the planning and implementation of the annual Medical Affairs strategy
  • Manage assigned publications budget
  • Manage the Scientific Medical Writing group
  • Cover poster and scientific sessions at select medical conferences and write debriefs.
  • Manage publication agencies
  • Act in line with legal, regulatory and company standards and codes of practice (such as our client' s Code of Conduct, Good Publications Practice, ICMJE recommendations and any other directives and guidelines)


Qualifications/ Requirements:

· Advanced degree scientific medical field (PhD, PharmD, MD)
  • 8+ years of professional experience in the pharmaceutical / biotechnology industry or related experience
  • Medical affairs, clinical development, or medical communications agency experience preferred, rare disease/neurology disease state related experience is preferred
  • Experience leading peer-reviewed publications, collaboration with scientific experts is required
  • Experience interpreting and presenting scientific data required
  • External agency and budget management experience required
  • Working knowledge of statistical concepts and techniques is required.
  • Experience in working with fast paced, collaborative, cross-functional teams
  • Knowledgeable of US and international regulations, requirements, and guidance’ s associated with scientific publications is required
  • Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.
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Mon, 26 Mar 2018 00:00:00 EDT 0
<![CDATA[Director of Compensation and Benefits]]> Our Client currently has an opportunity for a Director of Compensation and Benefits responsible for designing, developing and implementing efficient and effective compensation and benefit programs to meet current and future business needs and maintain a competitive advantage for the business as a whole. 

Job Responsibilities:
  • Analyze the effectiveness of existing compensation policies, guidelines, and procedures, recommending plan revisions, as well as new plans which are cost effective and consistent with compensation trends and corporate objectives; drives implementation and provides guidance to Sr. Executives, Management and HR staff.
  • Partner closely with company business leaders on a variety of compensation and benefit matters, including those related to the Company' s expansion initiatives.
  • Be on the forefront of evolving practices related to all aspects of Total Rewards; provide expert counsel and guidance to senior management on programs that are competitive in the industry and frequently benchmark best practices.
  • Ensure that all aspects of plan design and administration remains in compliance with applicable Federal, State and Local rules and regulations.
  • Provide recommendations to Sr. Executives, Management and HR staff on pay decisions, policy and guidelines interpretation and job evaluation, including the design of creative solutions to specific compensation-related programs.
  • Manage the administration of direct compensation (executive, exempt and nonexempt, cash compensation programs) including the processing, recording and reporting of compensation-related actions taken on salaried employees.
  • Direct the participation in market relevant exempt and nonexempt salary surveys to ensure corporate compensation objectives are achieved.
  • Manage the merit and bonus processes and makes program design recommendations based on relevant market data as defined by company compensation philosophy.
  • Research, analyze and recommend modifications to existing benefits plans to improve services to employees in a cost effective manner.
  • Oversee benefit plan contract negotiation meetings with vendors.
  • Recommend and help implement enhancements to benefits and compensation modules in the HRIS.
  • Partner with our corporate communications team as it relates to employee benefit communications.
  • Partner with our FK Global HR colleagues to implement global strategies and requirements. 


Qualifications/ Requirements:
  • Bachelor’ s degree; Masters preferred; Professional Certification desired
  • 7-10 years of management experience in compensation and benefits
  • Knowledge of HRIS and payroll systems
  • Advanced skills in Microsoft Excel and Word
  • Excellent verbal and written communication skills
  • Ability to communicate effectively with all levels of the organization
]]>
Fri, 23 Mar 2018 00:00:00 EDT 0
<![CDATA[Director, Regulatory Affairs]]> Our client is seeking a Director, Regulatory Affairs to lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.

Responsibilities:
  • Provide strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support R&D objectives.
  • Develop and create regulatory compliance strategies for multiple clinical development projects.
  • Coordinate all aspects of the preparation, review and submission of regulatory documents.  This includes the clinical and non-clinical portions of documents.
  • Represent the Regulatory Affairs Department as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements.
  • Serve as the Company’ s Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, MHRA, Health Canada and ROW with respect to clinical submission documents.
  • Provide leadership and direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs.
  • Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions.
  • Coordinate and maintain reporting schedules for regulatory applications.
  • Assure that all aspects of the Company’ s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
  • Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
  • Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.
  • Mentor and help develop the strategic & technical expertise of regulatory colleagues who are involved in supporting filings.

Requirements:
  • Bachelor’ s degree in a relevant scientific discipline.  Master’ s or an advanced degree (PhD, PharmD) is preferred.
  • 15+ years of regulatory affairs experience in the pharmaceutical industry.
  • Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements.
  • Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC).  Experience with regulatory filings in oncology is preferred.
  • Strong written and oral communication skills and the ability to interact effectively with project teams.
  • Ability to manage regulatory affairs activities and provide leadership in a “ hands-on fashion” while utilizing a strategic approach in all aspects of global compliance.
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Fri, 23 Mar 2018 00:00:00 EDT 0
<![CDATA[Director, Regulatory Affairs (Advertising & Promotion)]]> My client is seeking a creative, resourceful, strategic thinker for an important role that is responsible for overseeing the regulatory assessment of external communications regarding products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and serve as a the lead regulatory affairs representative on the oversight committees for our lead compound.

Job  Responsibilities:
  • Provide regulatory oversight of advertising and promotional activities for the Company’ s lead compound
  • Develop and implement strategies for achieving effective and compliant communications for commercially available products and investigational products.
  • Work collaboratively with cross-functional teams (stakeholders include Marketing, Medical Affairs, Legal, Compliance, R&D) from concept through approval, use and sunset to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.
  • Work collaboratively with cross-functional teams (Medical Science, Medical Affairs, Clinical Operations, Legal, etc) to ensure scientific and medical external communications are non-promotional and compliant with applicable regulations, guidelines corporate polices and product development objectives.
  • Oversee the compilation and submission of materials to Regulatory Authorities (e.g. OPDP) as applicable.
  • Correspond with Regulatory Agencies related to external communications for the Company’ s products.
  • Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
  • Work collaboratively with Compliance to ensure that approved materials are used within the intended guidelines and duration of use.
  • Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising
  • Participate in training of sales and marketing personnel on promotion, marketing, labeling and advertising regulations.


Qualifications/  Requirements:
  • Bachelor’ s Degree (B.S.) and a minimum of five to seven years related experience in Regulatory Affairs-Advertising and Promotion; minimum of ten years of biotech/pharmaceutical experience in various applicable roles.
  • At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
  • At least three (3) years in a team leadership role with highly effective people management skills
  • Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.
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Thu, 22 Mar 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
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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%
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Tue, 20 Mar 2018 00:00:00 EDT 0
<![CDATA[R&D Program Manager / Sr. Program Manager]]> My client is seeking a talented, motivated, and goal-oriented individual to join a growing Program Management team. The successful applicant will play an important role in supporting drug development teams.  This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific projects/programs, and to facilitate communication across all parties.   The ideal candidate will have experience working with late stage/commercialization projects. An engineering background is preferred but they are open for the right candidate.

This role is highly cross-functional, and may involve close interaction with external partners.

Job  Responsibilities:
  • Serve as project/program manager for one or more drug development teams, providing leadership, coordination, and cross-functional communication to enable teams to meet their goals;
  • Work with team members to compile high-quality, detailed, integrated cross-functional project/program plans, manage project activities, timelines, and resources;
  • Work with the project/program lead to facilitate decision making and resolve conflicts;
  • Work with the project/program lead and project/program team to identify key risks, timeline and resource constraints, and develop mitigation plans;
  • Effectively communicate project/program strategy, status, critical path activity timing, resource requirements, and related issues and/or risks, both internally and to partners, as appropriate;
  • Manage and maintain the team SharePoint site;
  • Effectively lead and manage team meetings by developing agendas, defining and communicating meeting objectives, capturing and disseminating meeting outcomes/information/minutes/action items, and following up on action item; 
  • Facilitate and contribute to the financial planning process, integrating inputs from functions and project/program teams into financial plans in collaboration with the Financial Planning & Analysis partners.
  • Help to create and improve program management tools and best practices.
  • Organize events to recognize team accomplishments.


Qualifications/Requirements:
  • A 4-year degree and a minimum of 3-5 years of relevant work experience including some project or program management.
  • Late stage/commercialization experience
  • Able to effectively lead team meetings and facilitate discussions within the team.
  • Demonstrate active listening and constructive feedback within team.
  • Ability to facilitate problem solving, decision making, and issue resolution.
  • Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite.
  • Strong program management and organizing skills: 
  • Communicating across the organization to align on shared goals and responsibilities;
  • Working with teams to clarify vision and direction;
  • Developing work plans to meet goals;
  • Managing multiple projects at the same time;
  • Managing teams to meet goals and deliverables, tracking progress toward plan;
  • Highlighting areas of risk and developing mitigation plans;
  • Identifying options and facilitating decisions to enable projects to move forward;
  • Working with teams to develop budgets, and tracking progress towards plans;
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Thu, 08 Mar 2018 00:00:00 EST 0
<![CDATA[Sr. Medical Director, Pharmacovigilance]]> Senior Medical Director, Pharmacovigilance

My client is looking for an experienced Sr. Medical Director/Medical Director of Drug Safety and Pharmacovigilance (DS&PV) that is a creative, resourceful and integrative thinker. The Sr. Medical Director/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 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.

 

Responsibilities:
  • Lead product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
  • 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

Requirements:
  • MD, MD PhD or MD MPH required
  • Minimum of 3-7 years’ experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry
  • Sound clinical acumen and decision making
  • 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
  • Level will be commensurate upon experience and qualifications.
  • Prior experience contributing to the development (process improvement, training, etc.) of a drug safety department would be desirable

 
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Thu, 08 Mar 2018 00:00:00 EST 0
<![CDATA[Sr. Medical Director, Surveillance and Risk Management]]> Our client is seeking a Sr. Medical Director, SRM and they will serve as the global lead for surveillance and risk management of all products marketed and in development.   This key position will lead a team of medical doctors and PV scientists, and interact across functions and at various management levels. The head of SRM and his/her team are responsible for the detection and investigation of safety signals, assessment of the need for risk mitigation activities, and the continuous benefit risk evaluation of all products. This role will interact with senior management and closely collaborate with colleagues from other functions such as Clinical Research, Regulatory Affairs, Data Science, Medical Affairs, Clinical Operations.

Job Responsibilities:

Key responsibility is to build and lead a high performing team of medical safety experts to:
  • Medically assess ICSRs from development and post-approval sources
  • Have an in depth understanding of product’ s safety profile as well as the patient profile in approved or studied indications
  • Monitor patient safety in clinical trials, in close collaboration with Clinical Research and Data Sciences
  • Lead Safety Management Teams
  • Evaluate safety data from various sources, including literature, clinical trials, internal and external safety databases. Propose proactive PV Strategies.
  • Apply, or introduce best industry practices to safety surveillance, including signal detection and assessment as well as benefit-risk evaluations.
  • Apply sound judgment in matters of recommended actions including label updates, risk mitigating activities and communications to health authorities, prescribers or consumers.
  • Produce excellent aggregate benefit-risk reports, and scientifically sound discussions and summaries, in support of decision making
  • Develop and propose post-market risk management plans, risk mitigation strategies as needed and monitor effectiveness

At the individual level, the head of SRM will:
  • Play a key role in the Company Safety Oversight Committee.
  • Interact with health authorities related to safety matters
  • Present to investigators, or other medical or professional audiences
  • Approve regulatory and clinical documents for submission.
  • Present or represent the DS PV position where needed
  • Report to the VP Drug Safety and Pharmacovigilance


Qualifications/ Requirements:
  • MD, DO, or equivalent
  • Minimum of (2) years Clinical experience after medical education
  • Minimum of (10) years industry experience in Pharmacovigilance and Risk Management
  • Track record of successfully leading teams.
  • Track record of successful safety issue management
  • Training or experience in quantitative research, epidemiology, public health
  • Extensive experience in both investigational and post-approval context
  • Board certification is a plus
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Mon, 05 Mar 2018 00:00:00 EST 0