Senior Director, Molecule Global Regulatory Lead

About this role

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 Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management. This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success.

In addition to strategic leadership, this role will build and scale fit-for-purpose regulatory processes, frameworks, and capabilities to support portfolio growth. The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.

Primary Responsibilities:

Global Regulatory Strategy

• Develop, own, and execute the global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management.

• Serve as the accountable global regulatory lead for assigned molecule(s), ensuring regulatory strategies support corporate objectives, development milestones, and global registration plans.

• Develop innovative regulatory approaches that enable efficient clinical development and maximize opportunities for expedited pathways.

• Anticipate regulatory risks, evaluate potential impact, and develop proactive mitigation strategies.

• Maintain and oversee the execution of the integrated global regulatory strategy for a product that aligns cross-functional development plans, regulatory requirements, and commercial objectives.

• Monitor the evolving global regulatory environment and provide regulatory intelligence that informs development strategy, competitive positioning, and organizational decision-making.

Health Authority Leadership

• Provide strategic oversight for global Health Authority interactions, including FDA, EMA, PMDA, MHRA, and other international agencies.

• Define the regulatory objectives, messaging, and overall strategy for key Health Authority meetings, including Pre-IND, End-of-Phase, Type B/C, Scientific Advice, and other critical interactions.

• Provide strategic guidance for the preparation of briefing documents, meeting requests, responses to agency questions, and regulatory correspondence.

• Interpret Health Authority feedback and translate it into actionable regulatory and development strategies for cross-functional teams.

Regulatory Submission Leadership

• Provide strategic oversight for the planning and execution of major regulatory submissions, including INDs, CTAs, amendments, expedited designation requests, marketing applications, and lifecycle submissions.

• Ensure submission strategies align with the overall global regulatory strategy, development objectives, and applicable regulatory requirements for the molecule.

• Provide strategic direction for the content and messaging of key regulatory documents to clearly communicate the scientific rationale, development strategy, and benefit-risk profile of assigned programs.

• Partner closely with Regulatory Operations, Medical Writing, Clinical Development, Biometrics, and CMC to deliver high-quality global submissions.

Cross-Functional Leadership

• Represent Regulatory as a core member of cross-functional molecule and development teams.

• Provide strategic regulatory guidance for clinical development plans, protocol design, indication expansion, and lifecycle opportunities.

• Partner closely with Clinical Development, Clinical Operations, Safety, Nonclinical, CMC, Biometrics, Medical Writing, Program Management, and Commercial to ensure regulatory strategy is fully integrated into program execution.

• Communicate regulatory strategy, risks, tradeoffs, and recommendations to senior leadership and governance committees.