Senior Clinical Scientist

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. We are seeking an accomplished Senior Clinical Scientist to join our Clinical Development team with a primary focus on GI oncology. This individual will play a strategic and operational role in the design, execution, analysis, and reporting of clinical trials, with particular responsibility for ensuring the accuracy, integrity, and regulatory compliance of clinical data used in NDA, BLA, and global submissions. The Senior Clinical Scientist will serve as a bridge between clinical research, data review, cleaning, regulatory science, and data management, partnering closely with physician leads, statisticians, regulatory affairs, CRO, clinical trial sites, and medical writing teams to deliver high-quality data packages that withstand global regulatory scrutiny. This role will also work with the cross-functional teams for the design, execution, and monitoring of clinical studies, as well as assist with data review, interpretation, and communication to both internal and external stakeholders. Oncology and/or late-stage experience is preferred. Drive clinical data review and cleaning activities, ensuring medical and scientific accuracy in patient-level data prior to database lock. Experience in preparation and/or review patient’s narratives (mini narratives and full narratives) for NDA/BLA submissions. Collaborate with Clinical Data Management to define data cleaning strategies, edit checks, and reconciliation processes across efficacy, safety, and biomarker datasets. Lead or co-lead clinical data review meetings, escalating scientific issues, resolving discrepancies, and ensuring traceability for regulatory filings. Strong working knowledge of data cleaning, database lock processes, and clinical data review. Proven ability to lead cross-functional clinical teams and contribute to strategic development plans. Contribute to clinical development strategy and execution of the Clinical Development Plan (CDP) with a focus on early-phase development. Contribute to the clinical data content of NDA, BLA, and MAA dossiers, including clinical study reports (CSRs), integrated summaries of safety/efficacy (ISS/ISE), and module 2.7 (2.7.3, 2.7.4, 2.7.5) of submission documents. Support regulatory agency interactions by preparing briefing documents, contributing to responses, and ensuring scientific consistency across submission components. Partner with cross-functional teams with oversight from senior team members to conduct clinical studies, including study start up, execution and close out activities, data review/analysis, and preparation of study reports. Contribute to the development of program-level documents, including but not limited to clinical protocols, investigator’s brochure, clinical study reports, abstracts and manuscripts, presentations, and various other internal and external documents and communications as needed. Conduct ongoing data reviews; prepare and present summaries to internal and external stakeholders. Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety. Interact with internal and external stakeholders (investigators, study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalation. Conduct literature reviews as needed. Travel: Up to 20%. Required Skills, Experience and Education: BS/BA or master’s degree in a scientific discipline, or other relevant advanced degree in a health science field. Preferred M.D. (or equivalent medical degree MBChB, MBBS). Minimum 6 years of experience in the pharmaceutical or biotechnology industry as a clinical scientist or related role. Minimum of 4 years’ experience supporting or leading data review and cleaning activities for NDA/BLA/MAA submissions in oncology or related therapeutic areas. Familiarity with statistical outputs and data visualization tools (e.g., Spotfire, R, SAS). Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment. Detail-oriented with ability prioritize tasks and function independently as appropriate. Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends. Proficient with software tools (Microsoft Office), Electronic Data Capture, and other custom web-based software. Excellent written and verbal communication skills. Preferred Skills Strong experience with clinical data review and data quality assurance. Knowledge and experience with clinical trial management and oversight, data cleaning, review and verification processes. Understanding and experience in clinical trial protocol and regulatory document authoring. The base pay salary range for this full-time position is $144,000 — $180,000 USD. 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.

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