Medical Director

Role Summary

Medical Director responsible for advancement of Sarepta’s clinical-stage programs, defining strategic priorities, and developing and executing the clinical development plan. Represents clinical development on the clinical study team, driving program development, approval, and commercialization of the asset. Requires strong 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 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: Proven ability to successfully manage multiple tasks and prioritize accordingly.
• Required: Proven ability to interact cross-functionally with strong presentation skills.
• Required: Willingness to travel.
• Required: Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Required: Intellectual curiosity, flexibility, drive, and resilience.

Skills

• Interpersonal and communication skills (written, verbal, visual)
• Cross-functional collaboration and leadership
• Data interpretation and program-level decision making

Education

• MD or PhD (required)
• Subspecialty training in neurology preferred

Additional Requirements

• Willingness to travel