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Revolution Medicines

Clinical-stage oncology company developing RAS inhibitors

Associate Director - Clinical Operations Compliance & Training

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRedwood City, CA, USA

About the Job

Requirements

  • A bachelor's degree in biological sciences or a health-related field is required.
  • At least 10 years of direct Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotechnology industry; relevant Clinical Operations experience may also meet the requirement.
  • Strong working knowledge of FDA regulations, International Council for Harmonisation guidelines, and Good Clinical Practice.
  • Demonstrated experience developing and authoring clinical and cross-functional standard operating procedures to ensure compliance with Good Clinical Practice and regulatory requirements.
  • Experience developing and monitoring oversight activities.
  • Knowledge of, or familiarity with, ex-US regions such as the European Medicines Agency, Medicines and Healthcare products Regulatory Agency, and Pharmaceuticals and Medical Devices Agency.
  • Ability to perform complex assessments and investigations, draw relevant conclusions, and implement appropriate solutions.
  • Ability to manage time demands, incomplete information, and unexpected events.
  • Strong organizational skills and ability to multitask and prioritize.
  • Interpersonal, verbal, and written communication skills.
  • Decision-making skills.
  • Ability to work in a fast-paced company environment and adjust workload based on changing priorities.
  • Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
  • Travel may be required, approximately 25%.

Responsibilities

  • Lead and/or support the development and implementation of Good Clinical Practice systems and inspection readiness.
  • Lead and/or support development and continuous improvement of clinical policies, standard operating procedures, work instructions, templates, and related materials using knowledge of clinical study management, International Council for Harmonisation guidelines, Good Clinical Practice, and regulatory requirements.
  • Serve as a subject matter expert for Clinical Operations Good Clinical Practice guidance, industry best practices, standard operating procedures, and audit responses.
  • Contribute to developing and managing business and compliance metrics to assess and continuously improve company oversight and inspection readiness throughout the clinical trial lifecycle.
  • Support Clinical Operations inspection-readiness activities with clinical study teams and participate in mock and regulatory authority inspections.
  • Contribute to developing and executing Clinical Operations training programs that deliver company standards, Good Clinical Practice, and regulatory requirements.
  • Partner cross-functionally and with Quality Assurance on quality initiatives, continuous improvement of Good Clinical Practice systems, and internal audits.
  • Perform line-management responsibilities, including hiring, performance management, career development, and mentorship.
  • Participate in other Clinical Operations activities as business needs require.

Desired Qualifications

  • Experience with line management.
  • Oncology experience in early- and/or late-stage settings.
  • Registered Nurse credential or a master's degree in biological sciences or a health-related field.
  • Strong working knowledge of ex-US regulations and requirements.
  • Experience with Microsoft Project and/or Smartsheet.

About the Company

Revolution Medicines

Clinical-stage oncology company developing RAS inhibitors

Revolution Medicines develops precision oncology drugs focused on cancers driven by RAS mutations. Its RAS(ON) inhibitors are small molecules that bind the active form of RAS to block cancer signaling, with candidates like Daraxonrasib (RMC-6236), Elironrasib (RMC-6291), and Zoldonrasib (RMC-9805) advancing in global Phase 3 trials. The company funds its research through collaborations, royalties, and upfront funding, and has not yet marketed a product. Its goal is to bring effective RAS-targeted therapies to patients and advance multiple candidates through late-stage trials toward approval, supported by strong cash reserves.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Redwood City, CA
Founded
2014

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