Full-Time Associate Medical Director, Clinical Development

About This RoleThe 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 programs and potentially contribute to other programs and/or develop our platform capabilities.

What You’ll Do

• Represent clinical development on 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 development and oversight of study protocols, 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.
• Contribute to the preparation and execution of investigator and advisory board meetings.
• Remain up to date on regulations and guidelines.

Who You Are

• Driven team member who can think globally about advancing therapeutic units.
• Understand clinical trial design, execution, and interpretation of results, and contribute to regulatory submissions.
• Effective in a matrixed environment.
• Possess expert knowledge of scientific, medical, and regulatory information for publications and presentations.

Required Skills

• MD, MD/Ph.D., Ph.D., or PharmD and at least 5 years of clinical research experience.
• Experience in analyzing and interpreting clinical data.
• Working knowledge of biostatistics, clinical trial design and execution, GCP, and regulatory requirements.
• High level of organizational and project management skills.
• Excellent written and verbal communication skills.
• Success in interacting with stakeholders (Clinical Operations, Regulatory, statistics, and clinical investigators).
• Ability to travel to scientific meetings and clinical sites (domestic and international).

Compensation

Base compensation range: $161,000 to $267,000.

Benefits

Medical, dental, life, disability insurances, vacation, end-of-year shutdown, and 401K participation.

Why Biogen?

• Commitment to excellence.
• Pioneering spirit.
• Environment where individual contributions make a significant impact.
• Delivering life-changing medicines.
• Building a culture of inclusion.

What is the last date for applying to the job?

Which countries are accepted for this remote job?