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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. The role will support daily compliance operational activities, evaluate risk, and resolve quality events for early phase through late‑phase clinical programs. It will also be responsible for managing multiple studies including GLP activities that impact clinical studies/data. This role reports to the Head of Clinical Quality.
Responsibilities
- Act as the study lead for Phase 3 program(s), providing support and guidance to the Clinical Development and Clinical Operations functions, including but not limited to 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, communicating 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 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. Documents include, but are not limited to, Study Protocols, ICFs, Annual Reports (e.g., DSUR), subject‑facing materials, Investigator’s Brochure, and CSR.
- Escalate quality events, IPDs, potential serious breaches to Quality Management and other relevant leadership as needed, 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 quarterly to quality management.
- 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, mentoring 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.
- Minimum of 15 years of pharmaceutical clinical quality assurance experience providing quality oversight and supporting multiple late‑stage clinical studies (Phase II–III).
- Extensive knowledge of relevant ICH E6, FDA, EMA, HC, 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–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 communicate with business partners and third‑party clinical vendors and their QA representatives to ensure RevMed requirements are met and to resolve issues/discrepancies.
- Oral and written presentation skills to address colleagues at all levels, e.g., internal training presentations, CRO performance metrics, and 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 associated processes, policies, and procedures.
Preferred Skills
- Experience managing oncology clinical studies and 4+ years of GLP quality assurance experience.
- An advanced degree is a plus.
Salary and Benefits
The base pay salary range for this full‑time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market for candidates based in other areas. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job‑related skills, experience, market dynamics, and relevant education or training.
Base Pay Salary Range: $201,000 – $251,000 USD.
Base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Equal Opportunity Statement
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, medical condition, and veteran status.
Privacy and Data Protection
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