Medical Director

Role Summary

Medical Director responsible for advancement of Sarepta’s clinical-stage programs. Defines strategic priorities for the program and integrates cross-functional input to develop and execute the clinical development plan. Represents clinical development on the clinical study team, driving program development, approval, and commercialization. Requires strong leadership and deep knowledge of the clinical drug development process from early/translational phases through to registration. This position is hybrid, with on-site work at a Sarepta facility in the United States and periodic attendance at in-person events.

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 maintain 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; 6-8+ years of hands-on pharmaceutical or biotech experience in clinical development; 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; ability to manage multiple tasks and prioritize; ability to interact cross-functionally with strong presentation skills; willingness to travel; ability to work collaboratively in a fast-paced, team-based matrix environment.
• Preferred: subspecialty training in neurology; rare/orphan diseases experience; demonstrated leadership in cross-functional settings; intellectual curiosity, flexibility, drive, and resilience.