Revolution Medicines · 14 hours ago
Associate Director, Clinical Operations, Compliance and Training
San Francisco Bay Area
Full-time
Hybrid
Lead/Staff, Director/Executive
$186K/yr - $233K/yr
10+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. As an Associate Director, you will lead the development and implementation of GCP systems, manage clinical policies, and support inspection readiness activities while overseeing team performance and training programs.
Health CareLife ScienceMedical
Responsibilities
Lead and/or support development and implementation of GCP systems and inspection readiness
Lead and/or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements
SME for Clinical Operations GCP guidance, best industry practices, SOPs, and audit responses
Contribute to the development and management of business and compliance metrics to assess and continuously improve RevMed oversight and inspection readiness throughout the clinical trial lifecycle
Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock/Regulatory Authority inspections
Contribute to the development and execution of Clinical Operations training programs to deliver RevMed standards, GCP, and regulatory requirements
Partner cross-functionally and with QA on quality initiatives, continuous improvement of GCP systems, and internal audits
Line management responsibilities including hiring, performance management, career development, and mentorship
Participate in other Clinical Operations Activities per the business need
Qualification
Required
Bachelor's degree in biological sciences or health-related field required
10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experiences may also meet the requirement
Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements
Experience with development and monitoring of oversight activities
Knowledge and/or familiarity with Ex-US region(s) e.g. EMA, MHRA, PDMA
Ability to perform complex assessments & investigations, draw relevant conclusions, and implement appropriate solutions
Strong analytical, negotiation, and persuasion skills
Ability to deal with time demands, incomplete information, or unexpected events
Outstanding organizational skills with the ability to multi-task and prioritize
Excellent interpersonal, verbal, and written communication skills
Decision-making skills
Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus
Travel may be required (~25%)
Preferred
Line Management experience
Oncology experience, early and/or late stage, strongly preferred
RN or Master's degree in biological sciences or health-related field preferred
Strong working knowledge of ex-US regulations and requirements
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
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase