Associate Medical Director, Clinical Development, Neuromuscular

Biogen•Cambridge, MA

2d•$194,000 - $267,000

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 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.

Requirements

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)

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

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