Associate Director, Clinical Operations Compliance & Training

Revolution Medicines•Redwood City, CA

23h•Hybrid

About The Position

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-6291), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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.

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 Microsoft 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.

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.