Associate Director, Clinical Operations, Compliance and 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 companys 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 Revolutionariesin 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 Lead or support 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:

• Bachelors 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 experienceOncology 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. #LI-Hybrid #LI-JC1