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Associate Director, Clinical Operations, Compliance and Training
About the position 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: As an Associate Director, you will be responsible for the following: Responsibilities • 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. • 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, continuous improvement of GCP systems, and internal audits. • Line management responsibilities including hiring, performance management, career development, and mentorship. • Participate in other Clinical Operations Activities per the business need. Requirements • Bachelor’s degree in biological sciences or health-related field required. • 10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations 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, MHRA, PDMA. • Ability to perform complex assessments & investigations, 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 arenaflex Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus. • Travel may be required (~25%). Nice-to-haves • Line Management experience. • Oncology experience, early and/or late stage, strongly preferred. • RN or Master’s degree in biological sciences or health-related field preferred. • Strong working knowledge of ex-US regulations and requirements. Apply tot his job
