Director, Global Pre-Approval Patient Access

The Opportunity:

The Director of Global Pre-Approval Patient Access will lead the strategy, design, and execution of global early access programs for Revolution Medicines’ pipeline. This role is critical to enabling appropriate patient access to investigational therapies targeting RAS-addicted cancers while ensuring alignment with clinical development/operations, regulatory requirements, and company priorities.

This role will report into the Head of Advocacy and Society Engagement and play an integral role in our commitment to supporting appropriate patient access to medicines.

• Develop and support global early access strategy aligned with clinical and regulatory milestones; ensure distinction with other patient access initiatives considered or implemented.

• Design and implement free of charge named-patient and cohort early access programs globally.

• Serve as overall cross-functional leader of the programs, liaising across Clinical, Regulatory, Medical Affairs, Commercial, Legal, Supply Chain, as needed.

• Establish governance for global evaluation, and prioritization of potential new programs.

• Oversee program operations, including vendors.

• Build policies, SOPs, and frameworks for ethical and compliant access decisions and ensure adherence to global SOPs and regulatory requirements.

• Partner with Development to ensure early access planning is aligned with Lifecycle strategy.

• During integrated strategic planning, coordinate closely with Supply Chain, Medical Affairs and Development to ensure supply readiness and feasibility assessments.

• Partner with global commercial teams around timing and transitions based on regulatory milestones and reimbursement.

• Manage budget, forecasting, and program KPIs.

Required Skills, Experience and Education:

The successful candidate will be a highly organized, proactive, resourceful, self-motivated individual with a roll-up-the-sleeves mentality and a strong sense of urgency. They should possess a proven track record of setting, driving, and delivering on objectives and projects, and have demonstrated ability to successfully collaborate with others.

• Bachelor degree in a healthcare field with 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 savvy with willingness and ability to work independently, think creatively, and shift gears depending on changing priorities and deadlines.

• Strong relationship management with a keen understanding of different roles inside of a biotech/pharmaceutical company.

• Significant experience leading large cross-functional teams.

• Proven ability to take initiative and consistently deliver high-quality solutions.

Preferred Skills:

• Experience with global product launches including support of launch planning.

• Strong knowledge of oncology drug development, including challenges associated with precision medicine and biomarker-driven trials.

• Ability to navigate complex ethical and operational decisions in high unmet need patient populations.

• Experience interacting with CROs, treating physicians, patient advocacy groups, and health authorities.

• Understanding of HTA/reimbursement timing impacts on pre-commercial access demand. 

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