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7 дней назад

Senior Director of Program Management (Gene Therapy)

214 000 - 292 000$
Формат работы
remote (только USA)/hybrid
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Director of Program Management (Gene Therapy): Leading late-stage gene therapy programs in neurology and rare disease from pivotal trials through regulatory approval and commercial launch with an accent on integrated planning, cross-functional governance, and launch readiness. Focus on managing vector manufacturing and regulatory risks, coordinating FDA and EMA strategies, and driving executive decisions across complex matrixed programs.

Location: San Diego, California, US; hybrid role with the option to work remotely most of the time and in-person collaboration when needed. Candidates on the US West Coast are preferred; other locations may be considered with travel as needed.

Salary: $214,000–$292,000 annual

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

  • Lead integrated, cross-functional program teams through late-stage clinical development, regulatory submission, approval, and commercial launch.
  • Own program strategy, execution, budgets, risks, timelines, resources, reporting, and stakeholder communications.
  • Develop and maintain Target Product Profiles, Integrated Development Plans, regulatory strategy roadmaps, launch readiness plans, risk registers, and program dashboards.
  • Coordinate Program Management, Regulatory Affairs, Medical Affairs, Market Access, Commercial, and Supply Chain teams to achieve launch readiness.
  • Support regulatory strategies and health-authority interactions involving expedited pathways such as Breakthrough Therapy, Accelerated Approval, and Orphan Drug Designation.
  • Mentor program management professionals and improve standardized processes for late-stage gene therapy delivery.

Requirements

  • Bachelor’s degree in a scientific or medical discipline; an advanced degree such as Ph.D., Pharm.D., M.D., or M.S. is advantageous.
  • 12+ years of program or project management experience in late-stage R&D within a biotech or biopharmaceutical environment.
  • Required hands-on experience with gene therapy or biologics, including scientific, manufacturing, and regulatory challenges.
  • Required experience directly supporting or leading at least one successful commercial product launch.
  • Required formal experience mentoring junior program management professionals in a matrixed environment.
  • Strong cross-functional leadership, executive communication, program governance, and program management tool skills; PMP certification is a plus.

Nice to have

  • Experience in neurology or rare disease and familiarity with orphan drug, breakthrough therapy, and accelerated approval pathways.
  • Advanced degree in gene therapy, neurology, rare disease, or molecular biology.
  • PMP certification.

Culture & Benefits

  • Flexible work schedules with purposeful in-person collaboration.
  • Medical, dental, vision, mental health, wellbeing, caregiver, fertility, and family-forming benefits.
  • Paid time off, 401(k) matching, annual equity awards, ESPP, and company-paid life and disability insurance.
  • Learning programs, mentorship connections, leadership development, employee resource groups, and volunteer opportunities.
  • Approximately 20–30% domestic and international travel is required.

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