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Job Description
Job DescriptionAbout This RoleThe Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU). Activities include direct responsibility for advancing clinical development assets (phase 1 to phase 3 stage) and/or multiple high priority label-enabling clinical programs through clinical study design and execution as well as interpretation and communication of study data. You will also assist the early research team in transitioning molecules from research to clinical development. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well as with global regulatory authorities.This role is based in Cambridge, MA, USA.What You'll Do- Provide medical and strategic leadership for multiple programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology, and input from the medical community around the world.
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).
- Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
- Gain approval from internal governance and advisory committees for CDP and study protocols.
- Represent Clinical Development on the cross-functional Product Development and Commercialization (PDC) Team and develop and maintain effective relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- Contribute to the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development.
- As appropriate, may serve as R&D Project Leader (RDPL) for specific projects.
Qualifications
MD, MD/PhD or PhD degree required; sub-specialty training in Neurology, Immunology, Neuroscience is preferred- Three (3) to five (5) years of experience in clinical research with a proven record of achievement.
- Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.
- Excellent communication skills (oral and written) and excellent organizational skills.
- Capacity and willingness to work effectively across disease areas.
- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
Additional Information
The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU). Activities include direct responsibility for advancing clinical development assets (phase 1 to phase 3 stage) and/or multiple high priority label-enabling clinical programs through clinical study design and execution as well as interpretation and communication of study data.
Vacancy expired!