Director, Global Pre-Approval Patient Access
New
R
Revolution MedicinesOncology Pharmaceuticals
Remote (United States)Full-TimeDirector
Salary201,000 - 251,000 USD per year
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Job Details
- Experience
- Minimum of 8 years
- Required Skills
- Cross-functional Team Leadership
Requirements
- Bachelor degree in a healthcare field; advanced degree preferred.
- Minimum of 8 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 key regulatory authorities’ programs and timelines.
- Excellent organizational skills with ability to work independently.
- Strong relationship management experience.
- Significant experience leading large cross-functional teams.
- Proven ability to take initiative and deliver high-quality solutions.
Responsibilities
- Develop and support global early access strategy aligned with clinical and regulatory milestones.
- Design and implement free of charge named-patient and cohort early access programs globally.
- Serve as overall cross-functional leader of the programs.
- Establish governance for global evaluation and prioritization of potential new programs.
- Oversee program operations and vendors.
- Build policies, SOPs, and frameworks for ethical and compliant access decisions.
- Partner with Development to ensure early access planning is aligned with Lifecycle strategy.
- Coordinate with Supply Chain, Medical Affairs and Development for supply readiness.
- Partner with global commercial teams on timing and transitions.
- Manage budget, forecasting, and program KPIs.
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