Travere Therapeutics - Oklahoma City, OK

posted 30 days ago

Full-time - Executive
Remote - Oklahoma City, OK
Administrative and Support Services

About the position

The Vice President of Clinical Development at Travere Therapeutics will serve as a strategic partner to the Chief Medical Officer, overseeing the planning and execution of rare nephrology and metabolic programs. This role involves managing cross-functional Project Strategy Teams and establishing global strategies for the development, approval, and commercialization of therapies targeting rare diseases. The ideal candidate will possess extensive clinical development leadership experience, particularly in nephrology and rare diseases, and will be responsible for driving programs and key deliverables in a matrix organization.

Responsibilities

  • Provide clinical leadership, guidance, and strategy to Travere's programs.
  • Manage the overall clinical development for Travere's programs, ensuring that clinical and regulatory milestones are met.
  • Guide the team through the development and/or update of the global strategic plan for successful development and commercial approval.
  • Provide scientific oversight and solicit expert input on important development choices, analyzing key risks and implications.
  • Effectively communicate program goals, strategies, plans, issues, and risks with team members and stakeholders.
  • Develop regulatory strategy and engage with the FDA, creating clinical development plans and timelines.
  • Manage clinical development including mentoring and leading clinical development physicians and scientists.
  • Develop aggressive but realistic Project Team goals, plans, timelines, and budgets with oversight of program execution.
  • Ensure appropriate communication channels are maintained and reporting schedules adhered to.
  • Engage strategically across multiple departments to ensure information dissemination and alignment across programs.
  • Collaborate with therapeutic leaders in medical affairs for publication strategy and KOL engagement.
  • Work with pharmacovigilance to ensure a holistic approach to monitoring and safety.
  • Develop and negotiate budgets and timelines, ensuring financial oversight of projects.
  • Present plans and strategies at scientific congresses and with regulatory agencies.
  • Represent programs and key decisions at cross-functional governance meetings.

Requirements

  • MD (nephrologist preferred) with 11+ years of experience in the pharmaceutical or biotechnology industry.
  • Direct experience in drug development with 5+ years of leadership experience.
  • Proven ability to manage strategic clinical development from pre-clinical through all clinical phases and product launch.
  • Excellent interpersonal, negotiation, influencing, and communication skills.
  • Experience leading and managing cross-functional drug development teams.
  • Experience developing and implementing clinical trials in the U.S. and internationally.
  • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
  • Ability to work in a team environment and prioritize multiple tasks.

Nice-to-haves

  • Experience with rare diseases and nephrology.
  • Experience with NDA/BLA submissions.
  • Experience building collaborations with CROs and pharmaceutical partners.

Benefits

  • Premium health insurance
  • Life insurance
  • Disability insurance
  • Retirement plans with employer match
  • Generous paid time off
  • Wellness and employee support programs
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