4 дня назад
Senior Director of Program Management (Gene Therapy)
214 000 - 292 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Director of Program Management (Gene Therapy): Leading late-stage neurology and rare disease gene therapy programs through pivotal trials, regulatory submission, approval, and commercial launch with an accent on integrated planning, cross-functional execution, and launch readiness. Focus on managing gene therapy risks, coordinating regulatory strategy, supporting FDA and EMA interactions, and driving executive governance across complex development programs.
Location: Hybrid role based out of the San Diego, California office; remote work is available most of the time with in-person collaboration, and candidates outside the area must be willing to travel as needed. Domestic and international travel of approximately 20–30% is required.
Salary: $214,000–$292,000 annual.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Serve as the operational COO for the Global Program Team and lead strategy execution across late-stage gene therapy programs.
- Direct integrated program planning, budgets, risks, timelines, resources, documentation, dashboards, and stakeholder communications.
- Lead programs through pivotal trials, regulatory submissions, approval, and commercial launch.
- Coordinate Regulatory Affairs, Medical Affairs, Market Access, Commercial, Supply Chain, and other functions to drive launch readiness.
- Manage scenario planning and gene therapy-specific risks, including vector manufacturing, batch release, immunogenicity, long-term follow-up, and health authority interactions.
- Mentor program management professionals and improve PMO processes, standards, and operating structures.
Requirements
- Bachelor’s degree in a scientific or medical discipline.
- 12+ years of program or project management experience, including leadership in late-stage R&D within a biotech or biopharmaceutical environment.
- Required hands-on experience with gene therapy, preferably viral-vector modalities such as AAV or lentiviral therapies, or with biologics.
- 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 scientific, cross-functional leadership, regulatory, communication, and program governance skills; PMP certification is a plus.
Nice to have
- Advanced degree such as Ph.D., Pharm.D., M.D., or M.S.
- Experience in neurology or rare diseases.
- Knowledge of Orphan Drug Designation, Breakthrough Therapy, Accelerated Approval, and other expedited regulatory pathways.
- Experience with tools such as MS Project, Excel, PowerPoint, SharePoint, or Veeva.
Culture & Benefits
- Purpose-driven environment focused on transforming the lives of patients with serious and rare diseases.
- Medical, dental, vision, mental health, wellbeing reimbursement, and Employee Assistance Program benefits.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship connections, employee resource groups, and service opportunities.
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