Associate Medical Director, Clinical Development, Neuromuscular
$194k - $267kBiogen
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
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
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.
- 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.
- Experience in device trials is strongly preferred.
- Experience in neurology and/or rare disease is preferred.
- 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)
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Vacancy posted 1 hour ago
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