Associate Medical Director, Clinical Development Movement Disorders
- Cambridge, MA
The Associate Medical Director, Clinical Development position sits within Biogen's Neurodegeneration Disease Unit. The role will support one or more clinical development programs focused in Movement Disorders. Activities include supporting the strategic design, execution, and interpretation of key clinical studies supporting high-priority Corporate initiatives.
The responsibilities within this role are:
- Supporting the strategic plan 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.
- Support the development approaches and protocols to demonstrate efficacy through the use of both clinical and biomarker endpoints.
- Potentially lead clinical study teams in conjunction with operations leads; provide medical oversight and direction; focus on study design and execution, ongoing medical data review to ensure data integrity; and review and interpretation of data
- Work collaboratively with internal and CRO cross-functional team members of study management teams and program teams
- Provide scientific input and contribute to the creation of relevant clinical documents, such as Investigators' Brochures, clinical trial protocols and Clinical Study Reports (CSRs) 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
- Contribute to business development evaluations
The ideal candidate will have the following mix of professional and personal characteristics:
- MD, Neuroscience background; Alzheimer's Disease or Movement Disorders preferred.
- Three (3) or more years of experience in clinical or laboratory research
- Clinical trial experience, particularly in development within the disease, is desirable
- Understand and able to put together and present analyses of data
- Strong organizational skills (oral and written)
- Excellent communication skills (oral and written) and excellent organizational skills
- Ability to represent the function on project teams, committees, and external meetings
- Ability to work effectively in a cross-functional team setting and employ a team approach to decision making
- Proven ability to work collaboratively with colleagues to direct clinical development plan
- Flexible and able to work in a fast-paced, rapidly changing environment
All your information will be kept confidential according to EEO guidelines.
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