Associate / Medical Director, Clinical Development, Neuromuscular

Job Description

About This Role

The Associate / Medical Director, Clinical Development, Neuromuscular sits within Biogen's Neuromuscular Development Unit . You will support one or more clinical development programs focused in Neuromuscular Disorders. Activities include supporting the strategic design, execution, and interpretation of key clinical studies supporting high-priority Corporate initiatives. In this high-visibility position you will interact with cross-functional teams within Biogen, and with external stakeholders.

What You’ll Do

•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 through the use of both clinical and biomarker endpoints
•Lead Phase 1-3 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 Clinical Development Plan (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 CDP
•Develop and maintain relationships with program counterparts in Regulatory, Clinical Operations, Data Management, Biomarkers, and Statistics
•Contribute to business development evaluations

Who You Are

You are a proven leader within the Clinical Development, Neuromuscular space and strive on developing, executing and advancing a strategic and successful development program. You have experience managing high performing teams; providing the necessary guidance and mentoring for all to reach their goals.

Qualifications

MD, MD/PhD or PhD degree in Neuroscience with experience in neuromuscular disorders preferred

•Three (3) to five (5) 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
•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

Location: Cambridge, MA (USA)



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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