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Executive Medical Director

Executive Medical Director

CompanySarepta
LocationCambridge, MA, USA
Salary$304000 – $380000
TypeFull-Time
DegreesPhD, MD
Experience LevelExpert or higher

Requirements

  • MD or PhD required, subspecialty training in neurology or gene therapy is preferred.
  • 10+ 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 skills in engaging with internal and external stakeholders, including regulatory agencies, industry partners, and senior corporate leadership.
  • 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.

Responsibilities

  • Functioning as a strategic leader within the function, overseeing multiple programs and/or a therapy area.
  • Leading a team to create and execute integrated development plans across these programs that provide strategic priorities and solutions to program challenges.
  • Partner with cross-functional leaders and governance bodies to provide leadership and direction to support the integrated development plan and drive cross-functional decision making.
  • 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.
  • Provide medical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development.
  • Maintain responsibility for the clinical development budget related to their programs or therapy area.
  • Lead innovative initiatives to enhance the company’s competitive edge in clinical development.

Preferred Qualifications

  • Subspecialty training in neurology or gene therapy is preferred.
  • Rare/orphan diseases experience preferred, but not required.