Contribute medical content and final medical review to clinical sections of study- and program-level documents such as protocols, ICFs, IB, briefing books, BTD, PIPs, SAPs, and safety periodic reports, providing risk-benefit framing and clinical rationale. Own ongoing review and monitoring of clinical data for quality, data integrity, data-trend investigation, and safety, including SAEs, SUSARs, protocol deviations, and periodic review of emerging safety, efficacy, PK, and biomarker data both internally and via SRC/DMCs.