Medical Director

Role Summary

Medical Director leads Sarepta’s clinical-stage programs, defines strategic priorities for the program, and develops and executes the clinical development plan. They represent clinical development on the clinical study team, driving program development, approval, and commercialization, and provide strong leadership across cross-functional teams throughout the drug development process from early/translational phases through registration.

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

Skills

• Clinical development leadership
• Regulatory engagement and documentation (INDs/NDAs/MAAs)
• Cross-functional collaboration and governance
• Clinical trial oversight and safety monitoring
• Data interpretation and program-level decision making
• Strong communication and presentation abilities

Education

• MD or PhD required; neurology subspecialty preferred.

Additional Requirements

• Willingness to travel.
• Hybrid work arrangement; on-site presence at Sarepta facilities in the United States and occasional attendance at Company-sponsored in-person events.
• Authorized to work in the United States.