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 early- and/or late-stage ALS programs and potentially contribute to other programs. This role will drive the progression of a deep clinical portfolio and assist cross-functional teams in achieving innovative clinical trial designs, biomarkers, clinical endpoints, and regulatory interactions.  

What You’ll Do

• Represent clinical development on cross-functional study management and/or program teams to ensure successful design and implementation of clinical studies in ALS
• 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, and contribution 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 supporting therapeutic area

Who You Are 

You are a driven team member who can think globally about advancing therapeutic units and work effectively across multiple studies and programs within the ALS space. You understand 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.

Qualifications

• MD, Ph.D., and/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, Biostatistics, and clinical investigators
• Ability to travel to scientific meetings and/or clinical sites as needed (domestic and international)

 

Job Level: Management

Additional Information

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