- Functioning as the clinical sciences team leader to create and execute an 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.
- If needed represent the CST on the global program team
- Establish and maintain positive relationships with clinical trial investigators/physicians, KOL's 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.
- Supports 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 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. #LI-Remote
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Director, Clinical Development - Cambridge, United States - Sarepta Therapeutics
Description
The Director, Clinical Development is responsible for leading a clinical sciences team 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. The individual may be called upon to represent the clinical sciences team on the global program team which provides cross-functional strategic leadership for the manufacturing, development, approval and commercialization of the program. 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.Primary Responsibilities Include:
Desired Education and Skills:
This position is remote. However, 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. 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.
