Associate Director, Clinical Operations Compliance & Training

Responsibilities

• Lead and support development and implementation of GCP systems and inspection readiness
• Develop and continuously improve Clinical Policies, SOPs, WIs, and Templates
• Serve as SME for Clinical Operations GCP guidance, best industry practices, and audit responses
• Manage business and compliance metrics to assess oversight and inspection readiness
• Support Clinical Operations Inspection Readiness and participate in Mock/Regulatory Authority inspections
• Develop and execute Clinical Operations training programs
• Partner cross-functionally with QA on quality initiatives and internal audits
• Provide line management including hiring, performance management, and mentorship

Requirements

• Bachelor’s degree in biological sciences or a health-related field
• 10+ years of direct Clinical Compliance or Clinical Quality Assurance experience in pharma or biotech
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
• Demonstrated experience authoring Clinical and cross-functional SOPs
• Experience with development and monitoring of oversight activities
• Proficiency in Microsoft Office Suite
• Ability to travel approximately 25%

Preferred Qualifications

• Line Management experience
• Oncology experience (early or late stage)
• RN or Master’s degree in biological sciences or a health-related field
• Knowledge of ex-US regulations (EMA, MHRA, PDMA)

About the Company

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.