Director, Clinical Quality

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 of Clinical Quality will play a key role in Quality Assurance and have direct responsibility for the clinical quality workstreams and study teams. This role is responsible for providing quality and compliance oversight for RevMed-sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices. This role will support daily compliance operational activities, evaluate risk, and resolve quality events for early phase through late-phase clinical programs. This role will also be responsible for managing multiple studies including GLP activities that impact clinical studies/data. This role will report to the Head of Clinical Quality. Act as the study lead for Phase 3 program(s), provide support and guidance to the Clinical Development and Clinical Operations functions, including but not limited to the following functional areas: Global Patient Safety, Translational Medicine, and Data Management. Lead the development and maintenance of applicable GCP Quality Systems procedures that comply with applicable GCP standards and guidelines. Work with Quality Leadership to develop a risk-based GCP audit program and compliance strategy for RevMed clinical study programs. Manage external GCP auditors and support timely review of audit reports and communicate findings to auditees, cross-functional representatives, and management. Ensure the corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate. Support global regulatory, due diligence and partner inspections at Sponsor including preparing the site, training the staff on regulatory inspection management best practices. Represent Clinical Quality during global regulatory inspections at RevMed including supporting regulatory inspections at clinical sites for RevMed clinical studies. Oversee study documentation including TMF for accuracy and inspection readiness. Perform quality reviews of Clinical Study Documents with a focus on compliance / regulatory requirements and risk assessment. The study documents include but are not limited to: Study Protocols, ICFs, Annual Reports (e.g., DSUR), other subject-facing documents (brochures, recruitment materials), Investigator’s Brochure, and CSR. Escalate quality events, IPDs, potential serious breaches to Quality Management and other relevant leadership as needed and in a timely manner including initiating CAPAs and CIs to address major findings and gaps. Compile, track GCP quality metrics (KPI) and vendor performance on all RevMed initiated clinical studies and report to quality management on a quarterly basis. Partner with GLP team members on activities that may impact GCP studies/data. Perform other assigned GCP or GXP tasks, as appropriate. Manage a team of clinical QA professionals and contractors and mentor QA staff. Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork. Required Skills, Experience and Education: A Bachelor of Science (B.S.) in a scientific or technical discipline is r