Associate Medical Director, Clinical Development

Summary

Join Biogen's Neuromuscular Development Unit as an Associate Medical Director and contribute to groundbreaking therapies for SMA and ALS. You will lead late-stage SMA programs, influence clinical trial designs, and collaborate with cross-functional teams. Responsibilities include overseeing study protocols, interpreting clinical trial results, and engaging with regulatory bodies. This role requires a medical degree (MD, MD/Ph.D., Ph.D., or PharmD) and at least 5 years of clinical research experience. Biogen offers a competitive salary, LTI grants, and a comprehensive benefits package.

Requirements

• MD, MD/Ph.D., Ph.D., or PharmD and at least 5 years of clinical research experience (academia or industry) is 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
• 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, statistics, and clinical investigators
• Ability to be flexible travel to scientific meetings and clinical sites as needed (domestic and international)

Responsibilities

• Represent clinical development on several cross-functional Study Management teams to ensure successful design and implementation of clinical studies in Spinal Muscular Atrophy (SMA) and achievement of study quality metrics
• Support the development and oversight of study protocols and amendments, clinical study reports, training documents, and other clinical and regulatory documents
• Responsible for clinical trial design, execution, and interpretation of clinical trial results, contribution to regulatory submissions and interactions, publications, and presentations
• Contributes 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 supporting therapeutic area

Benefits

• The base compensation range for this role is $161,000 to $267,000 base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job
• Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs
• Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions