Job Details

Vice President, Regulatory Affairs

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Vice President, Regulatory Affairs will manage several key U.S. based regulatory functions and report to the SVP of Regulatory and Quality. The position is responsible for expanding and leading a large, high functioning regulatory group and ensuring global alignment.

• Provide ethical and mission-driven leadership of the Regulatory Affairs functions. Embody and practice the company's mission-driven culture. Ensure that our core values guide our strategic vision and our day-to-day decision making.
• Provide a vision for the Regulatory Affairs organization and develop a plan to achieve it. Design and rapidly scale a group to meets the needs of an explosive pipeline in areas of high unmet medical need and intense industry competition.
• Influence decision-making of senior leadership and ensure globally aligned regulatory decision-making.
• Collaborate closely and form effective relationships with other functional heads and regional counterparts to ensure high quality, cross-functionally sound decision-making.
• Collaborate with peer leaders and management to ensure regulatory considerations are integrated upstream appropriately, e.g., target product profiles, clinical development plans, financial planning.
• Ensure consistency in approach (one playbook) and that learning occurs across staff and disciplines.
• Continue to build the Regulatory Affairs group, strategizing with other leaders to maximize enterprise-wide impact locally and globally.
• Actively lead the function and support team member career development.

Required Skills, Experience and Education:

• Local to San Francisco Bay Area or able to travel to headquarters frequently and for adequate durations (up to 25%).
• BA/BS degree in life sciences or related disciplines.
• At least 15 years of experience in drug development regulatory affairs.
• Minimum of 10 years of experience in regulatory leadership or executive role.
• Significant oncology experience.
• Expertise in navigating global regulatory environments in a commercial setting.
• Ability to successfully work in a fast-paced, demanding and highly cross-functional environment.
• Experience scaling an organization rapidly.
• Clearly understands the role of regulatory science in drug development and global commercialization, and is comfortable with ambiguity, risk, and optimizing for business needs.

Preferred Skills:

• Advanced degree in life sciences enabling technical fluency in oncology.
• Prior senior regulatory executive in oncology drug development at a medium or large pharmaceutical enterprise but who also understands the startup environment.