Associate Medical Director, Clinical Development, Neuromuscular
About The Position
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 late-stage SMA drug and device programs and potentially contribute to other programs and/or develop our platform capabilities. This role will drive the progression of a deep clinical portfolio and assist the team in achieving innovative clinical trial designs, biomarkers, clinical endpoints, and regulatory interactions. What You’ll Do 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. Who You Are You are a driven team member who can think globally about advancing therapeutics and work effectively with cross-functional partners across multiple studies within the SMA space. You have a strong understanding of 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.
Requirements
- 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.
- 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 clinical sites occasionally as needed (domestic and international)
Nice To Haves
- Experience in device trials is strongly preferred.
- Experience in neurology and/or rare disease is preferred.
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.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
