Associate Medical Director, Clinical Development, Neuromuscular

Role Summary

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.

Responsibilities

• 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

Qualifications

• Required: 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
• 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
• Required: Ability to travel to scientific meetings and/or clinical sites as needed (domestic and international)