Job Description

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.

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