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. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries 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 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, with practical application and execution of GLP and GCP requirements.

• 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).

• Ability to effectively