Senior Director, Global Pre-Approval Patient Access
New
R
Revolution MedicinesBiotechnology, Oncology
Remote (United States)Full-TimeDirector
Salary232,000 - 290,000 USD per year
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Job Details
- Experience
- Minimum of 12 years of clinical trial operations and Oncology EA experience
- Required Skills
- Project ManagementCross-functional Team LeadershipRelationship management
Requirements
- Bachelor degree in a healthcare field; advanced degree preferred.
- Minimum of 12 years of clinical trial operations and Oncology EA experience in a biotech/pharmaceutical company.
- Demonstrated ability to design and execute global EA programs.
- Deep understanding of global regulatory authorities’ programs and timelines.
- Significant experience leading large cross-functional teams.
- Proven track record of setting, driving, and delivering on objectives and projects.
- Strong relationship management skills with an understanding of roles within a biotech/pharmaceutical company.
- Ability to work independently and manage changing priorities.
- Experience with global product launches and launch planning is preferred.
- Strong knowledge of oncology drug development and biomarker-driven trials is preferred.
- Experience interacting with CROs, treating physicians, patient advocacy groups, and health authorities is preferred.
Responsibilities
- Lead the enterprise-wide strategy for early access (EA) programs aligned with clinical and regulatory milestones.
- Design and implement free-of-charge named-patient and cohort early access programs globally.
- Serve as the overall cross-functional leader, liaising across Clinical, Regulatory, Medical Affairs, Commercial, Legal, and Supply Chain teams.
- Chair governance for the global evaluation and prioritization of new programs.
- Establish company-wide policies, SOPs, and frameworks for ethical and compliant access decisions.
- Partner with Development and Lifecycle teams to align early access planning with broader strategy.
- Manage budget forecasting and program KPIs.
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