Director of 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 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 responsibility for the clinical quality workstreams reporting to the Head of Clinical Quality. This role is responsible for providing 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 complex issues through late-phase development. This role will also engage in GLP activities that impact clinical studies/data.

• Provide support and guidance for 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 that comply with applicable GCP standards and guidelines.

• Support a risk-based audit and compliance strategy for multiple programs.

• Support timely completion of comprehensive 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.

• Implement GLP/GCP inspection readiness activities.

• Interact with the FDA and other regulatory agencies, as needed.

• 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 identified issues to QA Management and other relevant leadership as needed and in a timely manner.

• Partner with GLP team members on activities that may impact GCP studies/data.

• Enable other assigned GCP or GXP tasks, as appropriate.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Experience, Skills, and Education:

• A Bachelor of Science (B.S.) in a scientific or technical discipline is required.

• Minimum of 12 years of pharmaceutical clinical quality assurance experience in support of clinical development and clinical operations.

• Extensive knowledge of relevant ICH, FDA, 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 commercial).

• Experience in hosting regulatory inspections and in dealing with regulatory agencies throughout the drug product approval process.

• Professional and respectful communication skills (verbal / written).

• Ability to effectively communicate with business partners and third-party clinical vendors and their quality assurance representatives to ensure RevMed requirements are met and to resolve issues/discrepancies.

• Oral and written presentation skills are needed to address colleagues at all levels of the organization, e.g., internal training presentations, presentations of CRO performance metrics, and coordination of inspection readiness activities.

• Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.

• Ability to contribute to the development, performance monitoring, and continuous improvement initiatives related to the company’s Quality Systems and their associated processes, policies, and procedures.

Preferred Skills:

• 4+ years of GLP quality assurance experience is preferred.

• An advanced degree is a plus.