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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in organizing and overseeing clinical compliance and training. As a Director, you will be responsible for GCP/ICH quality leadership, strategic development of quality initiatives and supporting quality culture in the execution of RevMed Clinical Development programs.  You will provide guidance and oversight of Clinical Operations (and as needed other Development functions) study activities to ensure clinical trials are conducted in a manner compliant with SOPs, ICJ/GCP/Regulatory guidelines and company goals.

• Strategically lead the Clinical Compliance & Training function to deliver knowledge, training, oversight, guidance and support, to promote and maintain GCP compliance for the operations and execution of Clinical Operations programs.

• Establish a governance and structured approach to develop and execute clinical operations quality initiatives, Standard Operating Procedures (SOP) in keeping with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines, as well as governing regulations and patient safety standards to maintain inspection readiness.

• Provide strategic quality operational guidance to ensure that clinical trials are properly defined, planned, and executed across all assigned clinical stage programs through tracking, creation, deployment, and management of systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities.

• Can identify critical path activities and articulate and mitigate risks to clinical study processes.

• Be the SME for Clinical Operations personnel for issues relating to GCP, SOPs, non-compliance surveillance, Quality Events, audit/inspection responses and process optimization.

• Partner with Clinical Operations and QA personnel in Root cause analyses and advises on content of CAPAs and audit/inspection responses.

• Drive the design, development and execution of development and training programs to support process quality and inspection readiness.

• Evaluate Development business units, Clinical Operations, and others as needed/defined, to design, develop and implement annual training plans.

• Lead the development, review and revision and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP guidelines and company policies to ensure inspection readiness.

• Partner with Clinical Operations, Clinical Sciences, QA, Clinical Data Sciences, Quantitative Sciences, Global Patient Safety and other RevMed compliance units to manage study-specific training and ensure adherence to GCP compliance execution.

• Work closely with Clinical Operations Leadership on Inspection Readiness initiatives, coordination and implementation.

• Partner with QA on remediation of quality issues related to clinical study conduct.

• Act as a liaison with QA to ensure coordination and communication of quality driven initiatives, to ensure alignment on compliance decision and recommended action implementation.

• Successful planning and deployment of staff for project and non-project related tasks. Establish clear roles and responsibilities for team members and include opportunities to stretch skills and enable growth.

• Line management responsibilities include hiring, performance management, career development, and mentorship.

• Support teams with long range planning, scenario analysis, and annual budget planning activities

• Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.

• Evaluate and align Clinical Operations initiatives across related continuous improvement processes and quality standards related to operational excellence.

• Support coordination of quarterly Clinical Operations Meetings for training purposes and process alignment.

Required Skills, Experience and Education:

• RN or bachelor’s or master’s degree in biological sciences or health-related field required.

• 15+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experience may also meet this requirement.

• Minimum of 7 years of project and line management experience.

• Intimate working knowledge of FDA Regulations, ICH Guidelines, and GCP related to late stage or post marketed products.

• Strong strategic/conceptual skills that can bridge the gap between different interdisciplinary departments, and a compliant clinical development operations structure and team.

• A demonstrable record of strong leadership and teamwork.

• Experience in evaluating, negotiating, and managing multiple successful relationships with partners, ability to set up milestones to track progress and working collaboratively with partners.

• 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, with ability to interact with colleagues and partners at all levels of experience are expected.

• Decision-making skills.

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

• Ability to act as an excellent ambassador for RevMed in interactions with key opinion leaders, scientific advisors, corporate partners, and where necessary, investors.

• Experience with hiring, training, developing, mentoring, and motivating team members to the highest level of performance.

• 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:

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com

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