Senior Clinical Programs Manager, GCP & Compliance

Revolution Medicines, Inc.; Redwood City (CA); On-site; USD 200,000 - 320,000; Full time

Job summary

Revolution Medicines is seeking a Sr. Clinical Program Manager to lead and advance Clinical Operations Compliance and Training. You will drive GCP infrastructure, author SOPs, and support inspection readiness across clinical trials in a fast-paced biotech environment.

The role requires 10+ years in clinical operations/compliance, deep FDA/GCP/ICH knowledge, and strong cross-functional collaboration. Some travel may be required as part of oversight and audits.

Qualifications

• 10+ years in Clinical Operations and/or Clinical Compliance in pharma/biotech.
• Experience developing and authoring Clinical SOPs ensuring GCP/regulatory compliance.
• Strong knowledge of FDA regulations, GCP and ICH guidelines.
• Excellent written/verbal communication and cross-functional collaboration.

Responsibilities

• Support GCP infrastructure and best industry practices within Clinical Operations.
• Develop and continuously improve Clinical Policies/SOPs/WIs/Templates in line with ICH/GCP and regulatory requirements.
• Manage oversight and inspection-readiness metrics across the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities.
• Contribute to Clinical Operations training programs on RevMed standards, GCP and regulatory requirements.
• Partner with QA on remediation plans, CAPAs and audit responses.
• Communicate deliverable status and solve problems to meet goals.
• Track project status and update key stakeholders.

Skills

FDA Regulations knowledge

GCP knowledge

ICH Guidelines knowledge

MS Office proficiency

Project management

Education

Biological/health sciences degree

Tools

MS Project

Smartsheet

Job description

Revolution Medicines is seeking a Sr. Clinical Program Manager to lead and advance Clinical Operations Compliance and Training. You will drive GCP infrastructure, author SOPs, and support inspection readiness across clinical trials in a fast-paced biotech environment.

The role requires 10+ years in clinical operations/compliance, deep FDA/GCP/ICH knowledge, and strong cross-functional collaboration. Some travel may be required as part of oversight and audits.