Medical Director or Assocaite Medical Director, Clinical Development –Alzheimer’s Disease & Dementia Research Unit
About The Position
Clinical Development sits in the Alzheimer’s Disease & Dementia Research Unit– a component of the Research and Early Clinical Development Organization. The appointment will be made at Medical Director or Associate Medical Director depending on the experience of the candidate. The appointee will support one or more development programs involving products in Alzheimer’s disease or a related dementia. The initial focus will be in designing and executing clinical trials in early development. Activities include direct responsibility for advancing high priority clinical programs through clinical study design and execution, development of biomarker strategies, as well as interpretation of data from key clinical studies. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community, along with global regulatory authorities. The responsibilities for the position are as follows: Provide strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world. Execute an early stage development program in Alzheimer’s disease. Integrate the 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 the 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 program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs. Contribute to the development of strategic initiatives and specified Business Development activities.
Requirements
- At the AD level, a minimum of one year of experience in clinical research (Medical Director will require significantly more experience).
- Industry experien
Responsibilities
- Provide strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world.
- Execute an early stage development program in Alzheimer’s disease.
- Integrate the 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 the 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 program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs.
- Contribute to the development of strategic initiatives and specified Business Development activities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
Number of Employees
1,001-5,000 employees
