Medical Director

Role Summary

The Medical Director is responsible for advancement of Sarepta’s clinical-stage programs. The individual defines strategic priorities for the program, integrates cross-functional input to develop and execute the clinical development plan, and represents clinical development on the clinical study team to drive program development, approval, and commercialization. Strong leadership and deep knowledge of the clinical drug development process from early/translational phases through registration are required.

Responsibilities

• Function as the clinical development leader to create and execute a clinical development plan that provides strategic priorities and solutions to program challenges.
• Partner with cross-functional leaders and governance bodies to provide leadership and direction to support the clinical development plan and drive cross-functional decision making.
• Establish and maintaining positive relationships with clinical trial investigators/physicians, KOLs and clinical advisors through independent collaborations and scientific meetings.
• Provide expertise and leadership to support protocol development, regulatory agency engagements, and documents including INDs and NDAs.
• Provide clinical oversight and medical monitoring for clinical trials; ensuring patient safety, protocol adherence, data quality and integrity, and compliance with ICH/GCP and regulatory requirements.
• Analyze, interpret, and contextualize clinical trial data to support program-level decision making.

Qualifications

• Required: MD or PhD; subspecialty training in neurology preferred.
• 6-8+ years of hands-on pharmaceutical or biotech experience in clinical development; rare/orphan diseases preferred, but not required.
• Prior IND/CTA and/or NDA/MAA filing experience.
• In-depth knowledge of the drug development process and oversight of clinical trials.
• Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics.
• Excellent interpersonal, written, verbal and visual communication skills.
• Proven ability to successfully manage multiple tasks and priorities.
• Proven ability to interact cross-functionally with strong presentation skills.
• Willingness to travel.
• Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Intellectual curiosity, flexibility, drive, and resilience.

Education

• MD or PhD; subspecialty training in neurology preferred.

Additional Requirements

• Willingness to travel.
• Hybrid work arrangement; on-site at Sarepta facilities in the United States and/or attendance at company-sponsored in-person events as required.