Medical Monitoring & Patient Safety Oversight — Lead Program Serve as the medical monitor for the program’s studies, providing real-time clinical judgment on eligibility, dose modifications, premedication compliance, and management of class-specific toxicities (e.g., effusions/edema, cutaneous reactions, hepatic abnormalities, hematologic toxicity).Perform detailed clinical data review of patient data profiles and other eCRF data (including drafting data queries, discussion of patient cases with Investigators, etc.).Lead ongoing benefit-risk assessment, including review of SAEs, AESIs (PBD-ADC class effects), and emerging safety signals; partner with Pharmacovigilance, DSMC/iDMC, and Biostatistics to ensure timely signal detection and risk mitigation. Cross-Functional Partner Partner with Translational Medicine, Biomarkers, and Biostatistics to characterize patient outcomes on the study drug (including by COO/GCB vs. non-GCB, double/triple-hit status, prior CAR-T exposure, and age/frailty), informing label strategy and lifecycle planning. Quality, Compliance & Inspection Readiness Ensure all medical monitoring and sBLA activities are conducted in compliance with ICH-GCP, FDA/EMA regulations, and internal SOPs; maintain audit- and inspection-ready documentation of clinical decisions and benefit-risk rationale in preparation for pre-approval inspections (BIMO) and sponsor inspections.
Qualifications:
MD required; MD/PhD preferred. Board certification in Hematology/Oncology (in U.S. clinic preferred).Some clinical experience treating aggressive B-cell lymphomas (DLBCL, HGBCL, transformed FL) strongly preferred.15+ years of clinical R&D experience in biopharma (or a combination of clinical and industry experience).Direct experience with antibody-drug conjugates (ADCs) — particularly PBD-based or CD19-targeted agents. Familiarity with the evolving DLBCL treatment landscape and ability to position the asset strategically within it.
