Medical Director

Role Summary

The Medical Director is responsible for advancement of Sarepta’s clinical-stage programs. The individual is responsible for defining strategic priorities for the program and integrating cross-functional input in order to develop and execute the clinical development plan. They will be called upon to represent clinical development on the clinical study team, which drives program development, approval, and commercialization of the asset. The individual must have strong team leadership skills and have deep knowledge of the clinical drug development process, spanning early/translational phases through to 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

• Required: MD or PhD; subspecialty training in neurology is 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 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

• Leadership and cross-functional collaboration
• Strategic thinking and decision making
• Strong communication and presentation skills

Education

• MD or PhD required