Revolution Medicines
Director, Clinical Quality
Revolution Medicines, San Francisco, California, United States, 94199
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Director, Clinical Quality
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Revolution Medicines . Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors for combination treatment strategies. As a member of the Revolution Medicines team, you will contribute to advancing therapies for cancers harboring mutations in the RAS signaling pathway. The Opportunity
The Director of Clinical Quality will lead quality assurance for RevMed-sponsored clinical trials, providing quality and compliance oversight for standards, regulatory requirements (FDA, EU, ICH & country-specific), and current industry practices. You will support daily compliance operations, evaluate risk, and resolve quality events across early to late-phase programs. You will manage multiple studies, including GLP activities impacting clinical studies/data, and report to the Head of Clinical Quality. Act as the study lead for Phase 3 programs, supporting Clinical Development and Clinical Operations across Global Patient Safety, Translational Medicine, and Data Management. Lead development and maintenance of GCP Quality Systems procedures that comply with applicable GCP standards and guidelines. Develop a risk-based GCP audit program and compliance strategy for RevMed clinical study programs. Manage external GCP auditors, review audit reports, communicate findings, and ensure CAPAs address root causes with effectiveness checks where appropriate. Support regulatory, due diligence, and partner inspections at Sponsor sites; prepare sites and staff for regulatory inspections. Represent Clinical Quality during global regulatory inspections, supporting inspections at clinical sites. Oversee study documentation including TMF for accuracy and inspection readiness. Perform quality reviews of Clinical Study Documents (e.g., Protocols, ICFs, DSURs, Investigator’s Brochure, CSR) with a focus on compliance and risk assessment. Escalate quality events, IPDs, and potential serious breaches; initiate CAPAs and CIs as needed. Compile and track GCP quality metrics and vendor performance; report to quality management quarterly. Partner with GLP team members on activities that may impact GCP studies/data. Manage a team of clinical QA professionals and contractors; mentor QA staff and build collaborative relationships across functions. Required Skills, Experience and Education Bachelor of Science (B.S.) in a scientific or technical discipline required. Minimum of 15 years of pharmaceutical clinical quality assurance experience overseeing multiple late-stage (Phase II–III) studies. Extensive knowledge of ICH E6, FDA, EMA, HC, PMDA and other regulatory requirements; practical application of GLP and GCP. Experience applying phase-appropriate quality systems across the product development lifecycle (Phase 1–III). Experience with regulatory inspections and engagement with regulatory agencies during drug product approval. Professional and respectful verbal and written communication skills; ability to communicate with business partners and CROs to ensure RevMed requirements are met and issues resolved. Strong presentation skills for internal trainings, CRO performance metrics, and inspection readiness activities. Ability to manage multiple projects, prioritize effectively, and collaborate cross-functionally in a dynamic environment. Ability to contribute to development, performance monitoring, and continuous improvement of Quality Systems, policies, and procedures. Preferred Skills Experience managing oncology clinical studies and 4+ years of GLP QA experience preferred. Advanced degree is a plus. Compensation and Benefits The base pay salary range for this full-time role at our Redwood City, CA headquarters is listed as a guide and may be adjusted for the local market. Base pay is one component of the total rewards package, which includes competitive cash compensation, equity awards, benefits, and opportunities for learning and development. Base Pay Salary Range: $204,000 — $255,000 USD. Equal Opportunity 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. Privacy Revolution Medicines takes protection and security of personal data seriously and respects your privacy. We collect, process, and use personal data in accordance with our CCPA Notice and Privacy Policy. For more information, contact privacy@revmed.com.
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Director, Clinical Quality
role at
Revolution Medicines . Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors for combination treatment strategies. As a member of the Revolution Medicines team, you will contribute to advancing therapies for cancers harboring mutations in the RAS signaling pathway. The Opportunity
The Director of Clinical Quality will lead quality assurance for RevMed-sponsored clinical trials, providing quality and compliance oversight for standards, regulatory requirements (FDA, EU, ICH & country-specific), and current industry practices. You will support daily compliance operations, evaluate risk, and resolve quality events across early to late-phase programs. You will manage multiple studies, including GLP activities impacting clinical studies/data, and report to the Head of Clinical Quality. Act as the study lead for Phase 3 programs, supporting Clinical Development and Clinical Operations across Global Patient Safety, Translational Medicine, and Data Management. Lead development and maintenance of GCP Quality Systems procedures that comply with applicable GCP standards and guidelines. Develop a risk-based GCP audit program and compliance strategy for RevMed clinical study programs. Manage external GCP auditors, review audit reports, communicate findings, and ensure CAPAs address root causes with effectiveness checks where appropriate. Support regulatory, due diligence, and partner inspections at Sponsor sites; prepare sites and staff for regulatory inspections. Represent Clinical Quality during global regulatory inspections, supporting inspections at clinical sites. Oversee study documentation including TMF for accuracy and inspection readiness. Perform quality reviews of Clinical Study Documents (e.g., Protocols, ICFs, DSURs, Investigator’s Brochure, CSR) with a focus on compliance and risk assessment. Escalate quality events, IPDs, and potential serious breaches; initiate CAPAs and CIs as needed. Compile and track GCP quality metrics and vendor performance; report to quality management quarterly. Partner with GLP team members on activities that may impact GCP studies/data. Manage a team of clinical QA professionals and contractors; mentor QA staff and build collaborative relationships across functions. Required Skills, Experience and Education Bachelor of Science (B.S.) in a scientific or technical discipline required. Minimum of 15 years of pharmaceutical clinical quality assurance experience overseeing multiple late-stage (Phase II–III) studies. Extensive knowledge of ICH E6, FDA, EMA, HC, PMDA and other regulatory requirements; practical application of GLP and GCP. Experience applying phase-appropriate quality systems across the product development lifecycle (Phase 1–III). Experience with regulatory inspections and engagement with regulatory agencies during drug product approval. Professional and respectful verbal and written communication skills; ability to communicate with business partners and CROs to ensure RevMed requirements are met and issues resolved. Strong presentation skills for internal trainings, CRO performance metrics, and inspection readiness activities. Ability to manage multiple projects, prioritize effectively, and collaborate cross-functionally in a dynamic environment. Ability to contribute to development, performance monitoring, and continuous improvement of Quality Systems, policies, and procedures. Preferred Skills Experience managing oncology clinical studies and 4+ years of GLP QA experience preferred. Advanced degree is a plus. Compensation and Benefits The base pay salary range for this full-time role at our Redwood City, CA headquarters is listed as a guide and may be adjusted for the local market. Base pay is one component of the total rewards package, which includes competitive cash compensation, equity awards, benefits, and opportunities for learning and development. Base Pay Salary Range: $204,000 — $255,000 USD. Equal Opportunity 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. Privacy Revolution Medicines takes protection and security of personal data seriously and respects your privacy. We collect, process, and use personal data in accordance with our CCPA Notice and Privacy Policy. For more information, contact privacy@revmed.com.
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