Associate Medical Director, Clinical Development, Neuromuscular

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.

Required Skills

MD, Ph.D., and/or Pharm

D 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)#LI-TD1

Job Level: Management Additional Information The base compensation range for this role is: $-$Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company  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

Emplo…