You're an experienced regulatory affairs leader with at least 14 years in the industry, including 10+ years focused on companion diagnostics or biomarker progra
Work type: hybrid
Location: Redwood City, California, United States
Salary: $244,000 – $305,000/yr
Type: Full-time
You're an experienced regulatory affairs leader with at least 14 years in the industry, including 10+ years focused on companion diagnostics or biomarker programs, holding an advanced degree in a relevant scientific field. **What makes it worth a look...** Revolution Medicines is offering a full-time, hybrid role in Redwood City, California, with a salary range of USD 244,000 - 305,000 per year. This position is crucial for aligning drug and diagnostic co-development globally. **You might be a good fit if you...** * Have deep expertise in NGS and PCR technologies, biomarker validation, and clinical implementation in oncology. * Demonstrate success leading FDA and global CDx regulatory submissions, including PMA/IDE and IVDR-related activities. * Are adept at leading complex, matrixed organizations and aligning diverse stakeholders. * Possess experience with regulatory strategies for US (FDA), EU (IVDR), and Japan (PMDA) markets.
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 Global Head of Regulatory Affairs for Companion Diagnostics (CDx) will define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio. This person will be accountable for the regulatory success of companion diagnostics supporting targeted therapies, ensuring synchronized drug–diagnostic co-development from discovery through global registration and launch. Ensure companion diagnostics are fully integrated into clinical development plans with no downstream regulatory surprises, that drug and CDx approvals are synchronized globally, enabling seamless registrational and commercial execution. Help make the company a leader in targeted oncology CDx development.
The role spans US, EU, and Asia-Pacific markets, with direct responsibility for aligning CDx development with clinical strategy, regulatory pathways, and commercialization plans. The successful candidate will operate as a strategic partner to Translational Sciences, Clinical Development, and Commercial partners.
Enterprise CDx Strategy & Leadership:
The 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.