Director, Clinical Quality

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 comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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. Responsibilities include: Act as the study lead for Phase 3 program(s), provide support and guidance to the Clinical Development and Clinical Operations functions. 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. 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. Escalate quality events, IPDs, potential serious breaches to Quality Management and other relevant leadership as needed and in a timely manner. 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. Manage a team of clinical QA professionals and contractors and mentor QA staff. Required Skills, Experience and Education: A Bachelor of Science (B.S.) in a scientific or technical discipline is required. Minimum of 15 years of pharmaceutical clinical quality assurance experience providing quality oversight and supporting multiple late-stage clinical studies (Phase II to III). Extensive knowledge of relevant ICH E6, FDA, EMA, HC and PMDA and other regulatory requirements and guidance documents. Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through Phase III). Experience in regulatory inspections and in dealing with regulatory agencies throughout the drug product approval process. Professional and respectful communication skills (verbal / written). 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.

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