Medical Director

Role Summary

Medical Director responsible for advancing Sarepta’s clinical-stage programs by defining strategic priorities and developing the clinical development plan. Leads cross-functional collaboration, represents clinical development on the study team, and drives program development, approval, and preparation for commercialization. Requires strong leadership and deep knowledge of the clinical drug development process from early translational stages 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

• MD or PhD required; 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 affairs, clinical pharmacology, and pharmacokinetics.
• Excellent interpersonal, written, verbal, and visual communication skills.
• Proven ability to manage multiple tasks and priorities; strong cross-functional collaboration and presentation skills.
• Willingness to travel.
• Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Intellectual curiosity, flexibility, drive, and resilience.

Skills

• Strong leadership and strategic thinking
• Cross-functional collaboration and relationship-building
• Regulatory affairs and clinical documentation proficiency
• Data interpretation and evidence-based decision making
• Effective communication and presentation abilities

Education

• MD or PhD required; neurology subspecialty training preferred

Additional Requirements

• Willingness to travel