Hiring: Medical Director Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-10 11:48:19 Employment Type: Full-time Target Skills & Keywords : Clinical Documentation, GCP, Pip, R, Regulatory Compliance About the job Experience: •5+ years’ experience in clinical development required in solid tumors generally, and GI Tumors (strongly preferred) . Required Skills: •Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio. •Partner cross-functionally with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements. •Lead clinical science aspects of the clinical development strategy and clinical documentation. •Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting. •Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings. •Actively facilitate and support Medical Monitors Medical Lead and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs). •Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents. •Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!