Medical Director

Role Summary

The Medical Director is responsible for advancement of Sarepta’s clinical-stage programs. The individual defines strategic priorities for the program, integrates cross-functional input to develop and execute the clinical development plan, and represents clinical development on the clinical study team to drive program development, approval, and commercialization. Strong leadership and deep knowledge of the clinical drug development process from early/translational phases through registration are required.

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; 6‚Äì8+ years of hands-on pharmaceutical or biotech experience in clinical development; experience with IND/CTA and/or NDA/MAA filings; 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; ability to manage multiple tasks and priorities; ability to interact cross-functionally with strong presentation skills; willingness to travel; ability to work in a fast-paced, team-based matrix environment; intellectual curiosity, flexibility, drive, and resilience.
• Preferred: Subspecialty training in neurology; experience in rare/orphan diseases; prior IND/CTA and/or NDA/MAA filing experience (if not already listed);.

Skills

• Strong leadership and cross-functional collaboration
• Strategic thinking and program management
• Medical monitoring and protocol/regulatory experience
• Investigators/KOL relationship management
• Effective communication and presentation skills

Education

• MD or PhD required (subspecialty in neurology preferred)

Additional Requirements

• Travel willingness
• Hybrid work arrangement; on-site in the United States and occasional in-person events