Associate Medical Director, Clinical Development, Neuromuscular

About This Role

The Neuromuscular Development Unit at Biogen is accountable for developing ground-breaking therapies in Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS), and muscle diseases from early to late-stage clinical development. As a member of the team, the associate medical director will work on late-stage SMA drug and device programs and potentially contribute to other programs and/or develop our platform capabilities. This role will drive the progression of a deep clinical portfolio and assist the team in achieving innovative clinical trial designs, biomarkers, clinical endpoints, and regulatory interactions. 

What You’ll Do

• Maintain accountability for clinical trial design, execution, and interpretation of clinical trial results for late-stage SMA drug and device programs.
• Support the development and oversight of study protocols and amendments, clinical study reports, training documents, and other clinical and regulatory documents.
• Represent clinical development on cross-functional study management teams to ensure successful design and execution of clinical studies and achievement of study quality metrics.
• Contribute to regulatory submissions and interactions, publications, and presentations.
• Contribute to the preparation and execution of investigator and advisory board meetings in partnership with project teams and stakeholders.
• Remain up to date on regulations and guidelines for the therapeutic area.

Who You Are

You are a driven team member who can think globally about advancing therapeutics and work effectively with cross-functional partners across multiple studies within the SMA space. You have a strong understanding of clinical trial design, execution, and interpretation of clinical trial results and contribute to regulatory submissions and interactions. You are effective in a highly matrixed environment and possess expert knowledge of scientific medical and regulatory information for publications and presentations.

Required Skills

• MD, Ph.D., and/or PharmD and at least 5 years of clinical research experience (academia or industry) required.
• Experience in analyzing and interpreting clinical data (safety and efficacy). Working knowledge of biostatistics, clinical trial design and execution, GCP, and regulatory requirements for clinical studies.
• Experience in device trials is strongly preferred.
• Experience in neurology and/or rare disease is preferred.
• High level of organizational and project management skills with the ability to work collaboratively in a fast-paced, team-based matrix environment.
• Excellent written and verbal communication skills.
• Demonstrated success in interacting and building relationships with various internal/external stakeholders, such as Clinical Operations, Regulatory, Biostatistics, and clinical investigators.
• Ability to travel to scientific meetings and clinical sites occasionally as needed (domestic and international)

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Job Level: Management

Additional Information

The base compensation range for this role is: $194,000.00-$267,000.00