Associate Medical Director, Clinical Development - Alzheimer’s disease, Dementia, & Movement Disorders
About The Position
The position of Associate Medical Director, Late Stage Clinical Development sits within the Alzheimer’s disease, Dementia, and Movement Disorders group reporting to a Medical Director or Senior Medical Director, Clinical Development. The new Associate Medical Director will support the aducanumab program. Activities include supporting the strategic design, execution, and interpretation of key clinical studies supporting this high-priority program as well as the support of global regulatory submissions. The individual who assumes this high-visibility position will interact with cross-functional teams and senior management within Biogen and with external stakeholders. The Associate Medical Director has the following responsibilities: Provide strategic leadership for study teams that integrate the individual’s knowledge in the disease area, knowledge from the medical community around the world and the commercial, research, regulatory, and medical research goals in the disease area. Develop approaches and protocols to demonstrate efficacy and safety through the use of both clinical biomarker endpoints. Lead Phase 2 and Phase 3 study teams in conjunction with operations leads; provide medical oversight and direction; focus on study execution, ongoing medical data review to ensure data integrity; and review and interpretation of data Work collaboratively with BIIB and CRO cross-functional team members of study management teams Provide scientific input and contribute to the creation of relevant clinical documents, such as Investigators' Brochures, clinical trial protocols, Clinical Study Reports (CSRs), or regulatory submissions to ensure high quality and accuracy Engage external experts to accumulate, review, analyze and communicate scientific and medical knowledge necessary to support clinical development Ensure studies and initiatives are consistent with overall program goals and CDP Medical monitoring of clinical studies; review and approval of protocol deviations and medical data on an ongoing basis Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the late stage Clinical Development Plan (CDP). Develop and maintain relationships with program counterparts in Regulatory, Clinical Operations, Data Management, Biomarkers, and Statistics. Contribute to the development of strategic initiatives, including various organizational initiatives in Clinical Development
Requirements
- Three (3) to five (5) years of experience in clinical or laboratory research
- Industry experience, particularly in development within the disease area inc
Responsibilities
- Provide strategic leadership for study teams that integrate the individual’s knowledge in the disease area, knowledge from the medical community around the world and the commercial, research, regulatory, and medical research goals in the disease area.
- Develop approaches and protocols to demonstrate efficacy and safety through the use of both clinical biomarker endpoints.
- Lead Phase 2 and Phase 3 study teams in conjunction with operations leads; provide medical oversight and direction; focus on study execution, ongoing medical data review to ensure data integrity; and review and interpretation of data
- Work collaboratively with BIIB and CRO cross-functional team members of study management teams
- Provide scientific input and contribute to the creation of relevant clinical documents, such as Investigators' Brochures, clinical trial protocols, Clinical Study Reports (CSRs), or regulatory submissions to ensure high quality and accuracy
- Engage external experts to accumulate, review, analyze and communicate scientific and medical knowledge necessary to support clinical development
- Ensure studies and initiatives are consistent with overall program goals and CDP
- Medical monitoring of clinical studies; review and approval of protocol deviations and medical data on an ongoing basis
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the late stage Clinical Development Plan (CDP).
- Develop and maintain relationships with program counterparts in Regulatory, Clinical Operations, Data Management, Biomarkers, and Statistics.
- Contribute to the development of strategic initiatives, including various organizational initiatives in Clinical Development
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
1,001-5,000 employees
