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Associate Director, Clinical Operations Compliance & Training

Revolution Medicines · Redwood City, CA

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Role summary

Revolution Medicines seeks an Associate Director to lead clinical operations compliance and training initiatives. This role oversees Good Clinical Practice systems, develops and implements compliance policies, supports inspection readiness, and manages a team within a precision oncology company advancing RAS-targeted therapies.

What they're looking for

  • Bachelor's degree in biological sciences or health-related field
  • 10+ years clinical compliance, quality assurance, or clinical operations experience in pharma/biotech
  • Strong working knowledge of FDA regulations, ICH guidelines, and GCP
  • Demonstrated experience developing and authoring clinical SOPs meeting GCP and regulatory standards
  • Experience with development and monitoring of oversight activities
  • Knowledge of international regulatory regions (EMA, MHRA, PMDA)
  • Ability to perform complex assessments and investigations with sound conclusions

What you'll be doing

  • Lead development and implementation of GCP systems and inspection readiness programs
  • Develop and improve clinical policies, SOPs, work instructions, and templates using GCP and regulatory knowledge
  • Serve as subject matter expert for clinical operations GCP guidance and audit responses
  • Develop and monitor business and compliance metrics for oversight and inspection readiness
  • Support clinical study teams with inspection readiness activities and mock regulatory inspections

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Date posted2 days ago
Last source check1 day ago
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