Associate Director, Clinical Operations Compliance & Training

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:

• 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.

Required Skills, Experience and Education:

• 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 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 Master’s degree in biological sciences or health-related field preferred.

• Strong working knowledge of ex-US regulations and requirements. 

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