Associate Director, Clinical TMF Management (Clinical Operations)

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:

This is a unique opportunity for a Trial Master File (TMF) Management Professional who has innate leadership and organizational skills, technical expertise in clinical Trial Master File management in an industry setting, and experience in the development and implementation of clinical systems strategy. As Associate Director Clinical TMF Management, you will be a key member of the Clinical Operations Excellence (CORE) team, responsible for the development and oversight of the Trial Master File strategy and standards, in support of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Serve as a key leader within Clinical Operations Excellence (CORE), a subfunction of Clinical Operations., providing strategic leadership and oversight of TMF activities across the RevMed portfolio.

• Accountable for strategic leadership and continuous improvement of Trial Master File (TMF) activities, ensuring scalable infrastructure and sustained inspection readiness across clinical programs.

• Lead and develop a team of CORE TMF Managers responsible for:

• Administration and operational oversight of the internal RevMed TMF, including management of the eTMF system vendor.

• Partnering with Clinical Study Teams to provide expert guidance and risk-based oversight to support high-quality TMF management.

• Supporting internal and CRO-managed study TMF start-up, ongoing quality oversight, close-out, and migration activities.

• Contributing to inspection readiness strategy and execution.

• Establish and maintain clear TMF governance and role delineation. Clinical study teams retain accountability for their study-specific TMFs; the AD, TMF Management ensures standards, oversight frameworks, tools, and support mechanisms enable consistent quality and compliance.

• Oversee internal and CRO-maintained TMFs to ensure alignment with RevMed standards, the CDISC TMF Reference Model, and global regulatory requirements.

• Develop and advance TMF strategy, processes, standards, SOP development, and quality frameworks to ensure completeness, timeliness, and audit readiness throughout the clinical trial lifecycle.

• Champion innovation in TMF management through implementation of technology-enabled and AI-supported solutions to enhance document quality, reconciliation, reporting, and inspection preparedness.

• Lead TMF-related vendor and CRO oversight, including expectation setting at study start-up, monitoring TMF health metrics and KPIs, proactive risk identification, and timely issue escalation and resolution, budget and resource strategy.

• Establish and monitor TMF performance dashboards and key risk indicators; conduct trend analysis and implement sustainable mitigation strategies to drive operational excellence.

• Identify critical path TMF risks and implement proactive mitigation strategies to protect study timelines, regulatory submissions, and inspection readiness.

• Provides strategic oversight, document strategy support, and remediation leadership as required during audits and regulatory inspections.

• Oversee TMF system strategy and optimization, including vendor management, system enhancements, integrations, and continuous improvement aligned with broader clinical systems strategy.

• Supervise, communicate system status, issues and problem solve to ensure TMF project goals are met.

• May manage or participate in implementation, development or management of other clinical systems and system integrations.

• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives.

• Lead TMF training, cross-functional collaboration, and continuous improvement initiatives to strengthen quality, efficiency, scalability, and long-term sustainability.

• Drive line management responsibilities including hiring, performance management, mentorship, succession planning, and development of a