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Program Lead, R&D, Drug Development

Cambridge, Massachusetts

Post Date: 09/14/2017 Job ID: 1481 Job Category: Clinical: R&D Program Management

My client is seeking a Program Leader who is a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program experience leading early to late stage drug development programs through launch and life-cycle management in the field of psychiatry and neurology.

The Program Leader will be responsible for leading and managing novel drug development projects and teams to successful development, NDA submission and market introduction.  This individual will work closely with all levels of leadership to determine program strategies and with internal and external groups to resource and implement all aspects of a drug development project. The Program Leader will set strategies and implement operating plans for the organization and be responsible for the overall project budget. The Program Leader will have access to all levels of the Leadership Team and will work closely with all the functional areas to plan, resource, implement and monitor programs.

Job  Responsibilities:
  • Provide effective leadership and direction for drug development programs and lead the Program Team.
  • Serve as Program Leader on one or more Program Teams, providing a model for effective team leadership within a matrix environment.
  • Accountable for meeting targets and managing deliverables.
  • Develop, prioritize, document and communicate measurable annual and long range plans.
  • Work closely with Medical Sciences, Regulatory Affairs, and Commercial to set team strategies through the Program Team.
  • Work with the relevant functions to identity key development and commercialization issues, develop plans to support market introduction, and proactively develop plans to support life-cycle management.
  • Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
  • Drives decision point planning and associated deliverables across all functions of the team Ensures the input from sub-teams to support the advancement of the program’ s objectives and deliverables
  • Assure that management is appraised, in a timely fashion, of the current status and issues surrounding each project.
  • Provide effective solutions for solving Program Team conflicts
  • Manage the program through effective budget planning and accountability, objective setting, performance appraisal and individual development, as appropriate.
  • Review and allocate resources in collaboration with functional areas and program teams
  • Provide sound strategic thinking related to regulatory interactions that lead to successful outcomes; attend key meetings with regulatory agency, as applicable.
  • Define and articulate clear strategic vision within program teams, serving as visible program champion and focal point for critical program information
  • Ability to design and influence new product concepts to R&D and the organization in general
  • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
  • Manage budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.


Qualifications/Requirements:
  • 15 years’ solid scientific background in pharmaceutical drug development with at least 10  years of experience in a project management function, and 5 years in a team leadership role.
  • Advanced degree in life sciences; a PhD or MBA is a plus
  • Have a past record of achievement in leading and managing project teams and product development with a thorough understanding of the drug development process at a strategic level through the entire lifecycle.
  • This position requires an individual with outstanding organizational and interpersonal skills.  It is essential that this individual can manage relationships and achieve results through influencing others in the organization.
  • Highly developed negotiation skills.
  • Strong knowledge of program budget process and resource allocation.
  • Superior oral and written communication skills are required, as is the ability to function effectively with senior management.
  • A strong focus toward creativity, independent thinking and results orientation is required.
  • Leading programs toward successful NDA/ MAA submissions.
  • Must have high ethical standards and impeccable integrity.
  • Must have highly developed personal leadership style and confidence.
  • Must be able to apply independent thinking, organizational abilities and strong discipline in a dynamic environment.
  • Must have strong detail orientation and be hands-on when needed to do what it takes and achieve key objectives.
  • Ability to understand stakeholder concerns and frame issues/proposals to influence decision making
  • Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
  • Capable of managing multiple programs/brands simultaneously
  • Issue Identification and Resolution
  • Cross-Functional Coordination and Communication including senior management
  • Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program.
  • Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
  • Be a diplomatic professional, ‘ clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients.
  • 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 in a matrix environment, as well as with external partners and vendors.

Rachel Ambroziak
Senior Recruiter

Rachel brings nearly 15 years of experience to The Steely Group, and specializes in Clinical Staffing. She is respected greatly for her tenacity, determination and great attention to detail. Her success in the recruiting industry is based, in part, on her passion for understanding the needs of both clients and candidates, as well as a commitment to providing exceptional customer service.
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