Revolution Medicines · 1 day ago
Director, Clinical Quality
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$194K/yr - $242K/yr
15+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Director of Clinical Quality will be responsible for quality assurance oversight of clinical trials, managing compliance with regulatory requirements, and leading quality systems development.
Health CareLife ScienceMedical
Responsibilities
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
Qualification
Required
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 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
Experience managing oncology clinical studies and 4+ years of GLP quality assurance experience is preferred
An advanced degree is a plus
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
2026-01-09
2026-01-09
Company data provided by crunchbase