revolutionmedicines
Associate Director, Clinical Operations Compliance & Training
At a Glance
- Location
- Redwood City, California, United States
- Work Regime
- hybrid
- Experience
- 10+ years
- Posted
- 2026-06-17T20:05:40-04:00
Key Requirements
Required Skills
Domain Knowledge
- Biotech
- Clinical
- Education
- Finance
- Medical
- Pharmaceutical
- Regulatory
Requirements
10+ years 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 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.
Line Management experience.
Responsibilities
As an Associate Director, you will be responsible for the following:
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.