Associate Medical Director, Clinical Development, Neuromuscular

Role Summary

The Associate Medical Director will contribute to late-stage SMA drug and device programs within Biogen’s Neuromuscular Development Unit and may support other programs and help develop platform capabilities. The role will drive progression of a deep clinical portfolio and assist the team in achieving innovative clinical trial designs, biomarkers, clinical endpoints, and regulatory interactions. This role collaborates across cross-functional teams to ensure rigorous study design, execution, and interpretation of results.

Responsibilities

• 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.

Qualifications

• Required: MD, Ph.D., and/or PharmD and at least 5 years of clinical research experience (academia or industry) required.
• 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.
• Preferred: Experience in device trials is strongly preferred.
• Preferred: Experience in neurology and/or rare disease is preferred.
• Required: High level of organizational and project management skills with the ability to work collaboratively in a fast-paced, team-based matrix environment.
• Required: Excellent written and verbal communication skills.
• Required: Demonstrated success in interacting and building relationships with various internal/external stakeholders, such as Clinical Operations, Regulatory, Biostatistics, and clinical investigators.

Additional Requirements

• Ability to travel to scientific meetings and clinical sites occasionally as needed (domestic and international).