Director, Regulatory Affairs Companion Diagnostics (CDx)

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 Director, Regulatory Affairs Companion Diagnostics is accountable for developing and executing global regulatory strategies for companion diagnostics supporting Revolution Medicines' precision oncology portfolio. This individual will serve as the regulatory lead for companion diagnostic development programs, partnering closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Science, Commercial, and external diagnostic partners to ensure successful co-development and global registration of therapeutic products and associated companion diagnostics. The Director will provide strategic regulatory leadership across all phases of companion diagnostic development, ensuring alignment between drug and diagnostic regulatory strategies, timelines, and submissions. This individual must possess a strong understanding of global in vitro diagnostic (IVD) regulations, companion diagnostic development, oncology drug development, and evolving global regulatory expectations. The successful candidate will be a collaborative leader with demonstrated experience managing complex cross-functional programs and interactions with health authorities and diagnostic partners. Develop and execute global regulatory strategies for companion diagnostics supporting oncology drug development programs from early development through commercialization. Serve as the Regulatory Lead for companion diagnostic programs, ensuring coordinated regulatory strategies between therapeutic and diagnostic products. Provide strategic regulatory guidance for companion diagnostic development plans, analytical and clinical validation, bridging strategies, labeling, and lifecycle management. Participate in regulatory interactions with FDA (CDRH and CDER), EMA, PMDA, and other global health authorities regarding companion diagnostic development and registration. Partner closely with external diagnostic manufacturers to support successful co-development, regulatory submissions, inspections, and post-approval activities. Ensure regulatory alignment between therapeutic and diagnostic submission timelines. Provide regulatory leadership for biomarker and precision medicine strategies supporting patient selection and clinical trial enrollment. Interpret evolving global regulations, guidance documents, and industry trends related to companion diagnostics and precision medicine, incorporating them into development strategies. Represent Companion Diagnostics Regulatory Affairs on cross-functional development teams and to senior leadership. Drive regulatory risk assessment and mitigation strategies to support development milestones and product approvals. Develop and maintain strong collaborative relationships across Regulatory Science, Clinical Development, Translational Medicine, Commercial, and external partners. Support development of regulatory policies, procedures, and best practices for companion diagnostics across the organization. Required Skills, Experience and Education: Advanced degree or bachelor’s degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline with a minimum of 12+ years of pharmaceutical, biotechnology, diag…