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Associate Director, Clinical Operations, Compliance and Training
Associate Director, Clinical Operations, Compliance and TrainingRevolution Medicines • Redwood City, CA, US
Associate Director, Clinical Operations, Compliance and Training

Associate Director, Clinical Operations, Compliance and Training

Revolution Medicines • Redwood City, CA, US
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Compliance Professional Opportunity

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity :

  • This is a unique opportunity for a Compliance Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting.
  • As an Associate Director, you will be responsible for leading or supporting the development and implementation of GCP systems and inspection readiness.
  • Lead 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.
  • 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 and continuous improvement of GCP systems.
  • 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 health-related field required.
  • 10+ years direct Clinical Operations and / or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant indirect experiences 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 region(s) e.g. EMA clinical trial operations.
  • Ability to perform complex analysis, 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 upon changing priorities.
  • Demonstrate proficiency in Microsoft Office Suite (Outlook, MS 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 Masters degree in biological sciences or health-related field preferred.
  • Strong working knowledge of ex-US regulations and requirements.
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    Associate Director Clinical • Redwood City, CA, US

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