Associate Director, Clinical Operations Compliance & Training

Revolution Medicines; San Francisco (CA); On-site; USD 186,000 - 233,000; Full time

Job summary

Revolution Medicines is hiring for a Clinical Compliance role in San Francisco, CA. The ideal candidate will have over 10 years of experience in Clinical Quality Assurance or Compliance within the pharmaceutical industry. Responsibilities include leading GCP system developments and inspections, authoring SOPs, and collaborating on audits. A Bachelor's degree in a relevant field is required, along with strong analytical and organizational skills. The position offers a base salary range of $186,000 to $233,000, based on market adjustments for remote candidates.

Qualifications

• 10+ years of direct Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry.
• Strong working knowledge of FDA regulations, ICH Guidelines, and GCP.
• Demonstrated proficiency in developing and authoring clinical SOPs ensuring compliance.

Responsibilities

• Lead and/or support development of GCP systems and inspection readiness.
• Contribute to management of clinical oversight metrics after trials.
• Partner cross-functionally on quality initiatives and audits.

Skills

Clinical Compliance

Clinical Quality Assurance

FDA regulations

GCP

Analytical skills

Interpersonal skills

Microsoft Office

Education

Bachelor’s degree in biological sciences or health-related field

Tools

Microsoft Office Suite

MS Project

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, including daraxonrasib (RMC‑6236), elironrasib (RMC‑6291), zoldonrasib (RMC‑9805) and RMC‑5127.

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

• 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, and other documentation using knowledge of ICH Guidelines, GCP, and regulatory requirements.
• Act as 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.

Required Skills, Experience and Education

• Bachelor’s degree in biological sciences or a health‑related field required.
• 10+ years of direct Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experience 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 regions (e.g., EMA, MHRA, PDMA).
• Ability to perform complex assessments and 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 on changing priorities.
• Demonstrated proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Skills

• Line‑management experience.
• Oncology experience, early and/or late stage, strongly preferred.
• RN or Master’s degree in biological sciences or a health‑related field preferred.
• Strong working knowledge of ex‑US regulations and requirements.

The base pay salary range for this full‑time position for candidates working onsite at our headquarters in Redwood City, CA is $186,000 – $233,000 USD. 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 if a candidate is based elsewhere.

Revolution Medicines is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process, and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [e-mail] so we can share these impersonations with our IT team for tracking and awareness.