Medical Director

Role Summary

The Medical Director leads Sarepta’s clinical-stage programs by defining strategic priorities and integrating cross-functional input to develop and execute the clinical development plan. They represent clinical development on the clinical study team, driving program development, approval, and commercialization of the asset. The role requires strong team leadership and deep knowledge of the clinical 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 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

• MD or PhD required; subspecialty training in neurology is 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 prioritize accordingly.
• 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 required.

Additional Requirements

• Hybrid work arrangement; on-site at a Sarepta facility in the United States and/or attendance at Company-sponsored in-person events from time to time.
• Candidates must be authorized to work in the U.S.