Director, Regulatory Affairs

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs y will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent Rev Med approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
• Motivate, mentor and develop direct reports to ensure development and performance.
• Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.
• Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.
• Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.
• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 15 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
• Proven success in developing and delivering global regulatory strategies and submissions.
• Demonstrated success in leading health authority interactions and negotiations.
• Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.
• Strong track record in alliance management, coordinating with external development or commercialization partners.
• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

• An advanced degree is desirable.
• Experience with dose optimization in oncology.
• Prior NDA experience is highly preferred.