Senior Clinical Sciences Leader

6 days ago


Cambridge, Massachusetts, United States Sarepta Therapeutics, Inc. Full time
Job Summary

The Director, Clinical Development is a key leadership position at Sarepta Therapeutics, Inc. responsible for leading a clinical sciences team that drives the advancement of our clinical-stage programs.

Key Responsibilities
  • Develop and execute a comprehensive clinical development plan that aligns with the company's strategic priorities.
  • Collaborate with cross-functional leaders and governance bodies to provide leadership and direction to support the clinical development plan.
  • Represent the clinical sciences team on the global program team, providing strategic leadership for the manufacturing, development, approval, and commercialization of our programs.
  • Establish and maintain positive relationships with clinical trial investigators, physicians, key opinion leaders, and clinical advisors through independent collaborations and scientific meetings.
  • Provide expertise and leadership to support protocol development, regulatory agency engagements, and document preparation, including INDs and BLAs.
  • Support key business initiatives, including providing strategic input on compounds in development and assessing their development strategies.
Requirements
  • MD and/or PhD required, with subspecialty training in neurology or gene therapy preferred.
  • 3-5 years of hands-on experience in pharmaceutical or biotech clinical development, with a focus on rare or orphan diseases.
  • Prior experience with IND/CTA and/or NDA/MAA filing.
  • 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.
  • Alignment with Sarepta's values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.


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