Senior Clinical Development Leader
2 months ago
The Director, Clinical Development is a key leadership position responsible for overseeing the clinical development of Sarepta's programs. This individual will lead a team of clinical scientists and work closely with cross-functional teams to develop and execute clinical development plans.
Key Responsibilities- Lead Clinical Development Team: Function as the clinical sciences team leader to create and execute a clinical development plan that provides strategic priorities and solutions to program challenges.
- Partner with Cross-Functional Teams: 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 Clinical Sciences Team: 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 Relationships: Establish and maintain positive relationships with clinical trial investigators/physicians, KOLs, and clinical advisors through independent collaborations and scientific meetings.
- Provide Expertise: Provide expertise and leadership to support protocol development, regulatory agency engagements, and documents including INDs and BLAs.
- Support Business Initiatives: Supports key business initiatives including providing strategic input on compounds in development and assessment of their development strategies.
- Education: MD and/or PhD required, subspecialty training in neurology or gene therapy is preferred.
- Experience: 3-5 years of hands-on pharmaceutical or biotech experience in clinical development; Rare/orphan diseases preferred, but not required.
- Skills: Prior IND/CTA and/or NDA/MAA filing experience, in-depth knowledge of drug development process and oversight of clinical trials, working knowledge of biostatistics, regulatory, clinical pharmacology, and pharmacokinetics.
- Personal Qualities: 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.
The targeted salary range for this position is $180,000 - $225,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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