Medical Director

Role Summary

The Medical Director leads Sarepta’s clinical-stage programs, defines strategic priorities for the program, and integrates cross-functional input to develop and execute the clinical development plan. The role represents clinical development on the clinical study team, driving program development, regulatory interactions, and eventual commercialization readiness. Strong leadership and deep knowledge of the clinical drug development process across early/translational stages through registration are essential.

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 regulatory compliance (ICH/GCP and applicable requirements).
• Analyze, interpret, and contextualize clinical trial data to support program-level decision making.

Qualifications

• Required: MD or PhD; hands-on pharmaceutical or biotech experience in clinical development (6‚Äì8+ years); prior IND/CTA and/or NDA/MAA filing experience; 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 in a fast-paced, team-based matrix environment.
• Preferred: Subspecialty training in neurology; experience in rare/orphan diseases; deep knowledge of the drug development process and oversight of clinical trials.

Skills

• Clinical development strategy and program leadership
• Regulatory engagement and document preparation (INDs, NDAs, MAAs)
• Trial oversight, patient safety, data quality, and regulatory compliance
• Cross-functional collaboration and stakeholder management
• Biostatistics, regulatory affairs, clinical pharmacology, and pharmacokinetics
• Strong written, verbal, and visual communication; presentation skills

Education

• MD or PhD required; subspecialty training in neurology preferred

Additional Requirements

• Willingness to travel