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Clinical Development Director
2 months ago
The Director, Clinical Development is a key leadership position responsible for driving the advancement of Sarepta's clinical-stage programs. This individual will lead a clinical sciences team, defining strategic priorities and integrating cross-functional input to develop and execute the clinical development plan.
Key Responsibilities- Develop 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.
- Represent the clinical sciences team on the global program team, providing cross-functional strategic leadership for the manufacturing, development, approval, and commercialization of the program.
- 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 BLAs.
- Support key business initiatives, including providing strategic input on compounds in development and assessment of their development strategies.
- MD and/or PhD required, subspecialty training in neurology or gene therapy is preferred.
- 3-5 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, clinical pharmacology, and pharmacokinetics.
- Excellent interpersonal, written, verbal, and visual communication skills.
- Proven ability to successfully manage multiple tasks and prioritize accordingly.
- Proven ability to interact cross-functionally with strong presentation skills.
- Willingness to travel.
- Recognized by former peers, colleagues, managers, and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.
Sarepta Therapeutics offers a competitive compensation and benefit package. This position is remote, but you will be expected to work on-site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $180,000 - $225,000 per year.
