SalaryUSD TBD TBD
Sr. Director, Clinical Development Acute Neurology/StrokeMassachusetts, Cambridge, 02138 Cambridge USA
The position of Senior Medical Director, Clinical Development is a leadership member of the Therapeutics Development Unit. This position will be critical in delivering a global, pivotal Phase 3 stroke trial as well as oversight for other trials within acute neurology. The Senior Medical Director will join a group of talented clinical development specialists focused on stroke and brain contusion and reporting directly to the Head of Development Therapeutics.
Biogen is unique in its focus on neuroscience, and has an innovative pipeline in acute neurology, with an opportunistic approach to expansion. The successful candidate will play a key role in advancing the current acute neurology pipeline and in enriching and expanding its scope. Through their responsibility for multiple clinical programs, they will drive innovation in clinical study design and endpoints, actively participate in development of biomarker strategies, and oversee the interpretation of data from key clinical studies. This will require close collaboration with members of cross-functional teams, modality experts and others in late-stage clinical development and beyond. A key opportunity will be to interact with multiple levels of management within Biogen, peers and leaders in companies involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.
The Senior Medical Director has the following responsibilities:
- Support the Head of Development Therapeutics for all affairs related to acute neurology.
- Represent the acute neurology team and portfolio in relevant governance and strategic forums
- Provide strategic leadership across acute neurology, executing late-stage development program(s) while providing mentorship and oversight to team members for their programs.
- Integrate scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, product development plan, and commercial goals to build a solid strategic framework for each clinical development plan (CDP).
- Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.
- Develop and maintain relationships with R&D Project Leaders and program counterparts in Commercial, Research, Regulatory, Biomarkers, Clinical Operations and Statistics.
- Establish and drive external collaborations, forge relationships with key opinion leaders and partners.
- Contribute to specified Business Development activities.
- Present and publish high-level clinical data in international meetings and journals.
The ideal candidate will have the following mix of professional and personal characteristics:
- MD, or MD / PhD credentials
- Neurology training with sub specialization in neurocritical care and/or other degenerative CNS disorders preferred
- At least eight (8) years of overall relevant experience within pharmaceutical/biotech industry and a background of clinical research is required. Clinical drug development experience is essential, stroke experience preferred but not required. or academic medicine
- Extensive knowledge of basic and clinical science, broad understanding of the neurology disease areas, established links with the medical community around the world
- Demonstrated dynamic leadership and team-building skills as well as the ability to perform effectively in an adaptive environment
- Demonstrated strategic and critical thinking
- The ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
- Able to facilitate discussions among groups with diverse technical expertise and drive decisions on complex issues
Biogen is unique in its focus on neuroscience, and has an innovative pipeline in acute neurology, with an opportunistic approach to expansion. The successful candidate will play a key role in advancing the current acute neurology pipeline and in enriching and expanding its scope. Through their responsibility for multiple clinical programs, they will drive innovation in clinical study design and endpoints, actively participate in development of biomarker strategies, and oversee the interpretation of data from key clinical studies.
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