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, diagnostics, or combination product experience, including at least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics.Demonstrated experience developing and executing global regulatory strategies for companion diagnostics supporting oncology or precision medicine programs.Deep knowledge of FDA companion diagnostic guidance, PMA requirements, IDE regulations, IVDR, and global IVD regulatory frameworks.Experience leading regulatory interactions with FDA CDRH and CDER, EMA, PMDA, and other international health authorities.Demonstrated success managing regulatory aspects of drug-diagnostic co-development programs through product approval.Experience working with external diagnostic partners.Strong understanding of biomarker development, assay validation, analytical performance studies, clinical performance studies, and companion diagnostic lifecycle management.Proven ability to influence cross-functional teams and integrate regulatory strategy across drug and diagnostic development organizations.Excellent communication, leadership, negotiation, planning, and organizational skills with the ability to manage multiple complex programs simultaneously.Experience representing Regulatory Affairs to senior leadership and executive governance committees.Preferred Skills:Advanced degree (PhD, PharmD, MD, MS, or equivalent) is preferred.Experience supporting global oncology registration programs involving companion diagnostics.Working knowledge of EU IVDR implementation and international companion diagnostic regulations.Experience supporting next-generation sequencing (NGS), PCR-based, or multiplex molecular diagnostics. #LI-Hybrid #LI-JC1The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact View email address on click.appcast.io Pay Salary Range$211,000—$264,000 USDWe are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to View email address on click.appcast.io so we can share these impersonations with our IT team for tracking and awareness.