Director, Regulatory Affairs Companion Diagnostics (CDx)

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin 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 companys portfolio. This person will be accountable for the regulatory success of companion diagnostics supporting targeted therapies ensuring synchronized drugdiagnostic 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:

Define and execute a global companion diagnostic regulatory strategy aligned with the companys precision oncology pipeline and long-term portfolio vision.
Ensure early and durable integration of biomarker and CDx strategies into clinical development programs from first-in-human through registration.
Build and lead a high-performing global regulatory CDx organization fostering a culture of scientific rigor accountability collaboration and execution excellence.
Own and manage the global regulatory CDx operating budget ensuring efficient allocation of resources to maximize program value and regulatory success.

Global Regulatory Strategy & External Partnerships:

Develop and direct global regulatory strategies for companion diagnostics including:
- FDA (PMA sPMA IDE 21 CFR 809/812)
- EU IVDR (Regulation (EU) 2017/746)
- PMDA (Japan) and other key ex-US authorities
Ensure alignment of therapeutic and diagnostic regulatory timelines including coordinated NDA and CDx submissions across programs.
Have input on the selection governance and performance management of diagnostic partners.
Provide regulatory leadership on bridging strategies analytical validation plans and global testing approaches to support registrational claims and post-approval lifecycle management.

Commercial & Launch Readiness:

Partner with Commercial Market Access and Medical Affairs teams to ensure successful global CDx launch readiness including:
- Labeling alignment
- Reimbursement and access strategy
- Testing infrastructure and adoption

Required Skills Experience and Education:

Advanced relevant technical degree in Molecular Biology Pathology Genetics or a related discipline.
12 years of experience in pharmaceutical biotechnology or diagnostics organizations including 10 years leading companion diagnostics or biomarker-driven programs.
Demonstrated success leading FDA and global CDx regulatory submissions including PMA/IDE and IVDR-related activities.
Deep expertise in NGS and PCR technologies biomarker validation and clinical implementation in oncology.
Proven ability to lead complex matrixed organizations and drive alignment across scientific clinical regulatory and commercial stakeholders.

Preferred Skills:

Prior experience supporting registrational oncology trials with companion diagnostics.
Track record of successful drugdiagnostic co-launches.
Established external network with diagnostic manufacturers CROs and global regulators.
#LI-Hybrid #LI-JC1

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.

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 ourCCPA additional information please contact .

Base Pay Salary Range

$211000$264000 USD

Required Experience:

Director