Senior Clinical Development Physician (Contractor)
ADC Therapeutics
August 20, 2026
Remote
United States
Clinical Research and Development
Remote (30–40 hrs/week; preference for New Jersey/East Coast based) Senior Clinical Development Physician Contractor for the ZYNLONTA Program
Key Responsibilities:
- Serve as medical monitor for ZYNLONTA studies; provide 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).
- Review clinical data profiles and eCRF data; draft data queries and discuss patient cases with Investigators.
- Lead ongoing benefit-risk assessment by reviewing SAEs, AESIs (PBD-ADC class effects), and emerging safety signals; partner with Pharmacovigilance, DSMC/iDMC, and Biostatistics for timely signal detection and risk mitigation.
- Partner with Translational Medicine, Biomarkers, and Biostatistics to characterize patient outcomes (COO/GCB vs non-GCB, double/triple-hit status, prior CAR-T exposure, age/frailty) to inform label strategy and lifecycle planning.
- Ensure medical monitoring and sBLA activities comply with ICH-GCP, FDA/EMA regulations, and internal SOPs; maintain audit/inspection-ready documentation for pre-approval and sponsor inspections.
Minimum Qualifications:
- MD required; MD/PhD preferred.
- Board certification in Hematology/Oncology (U.S. clinic preferred).
- 15+ years of clinical R&D experience in biopharma (or combined clinical/industry experience).
- Direct ADC experience (especially PBD-based or CD19-targeted agents).
Strongly Preferred:
- Clinical experience treating aggressive B-cell lymphomas (DLBCL, HGBCL, transformed FL).
- Familiarity with evolving DLBCL treatment landscape; ability to position ZYNLONTA strategically.
Key Responsibilities:
- Serve as medical monitor for ZYNLONTA studies; provide 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).
- Review clinical data profiles and eCRF data; draft data queries and discuss patient cases with Investigators.
- Lead ongoing benefit-risk assessment by reviewing SAEs, AESIs (PBD-ADC class effects), and emerging safety signals; partner with Pharmacovigilance, DSMC/iDMC, and Biostatistics for timely signal detection and risk mitigation.
- Partner with Translational Medicine, Biomarkers, and Biostatistics to characterize patient outcomes (COO/GCB vs non-GCB, double/triple-hit status, prior CAR-T exposure, age/frailty) to inform label strategy and lifecycle planning.
- Ensure medical monitoring and sBLA activities comply with ICH-GCP, FDA/EMA regulations, and internal SOPs; maintain audit/inspection-ready documentation for pre-approval and sponsor inspections.
Minimum Qualifications:
- MD required; MD/PhD preferred.
- Board certification in Hematology/Oncology (U.S. clinic preferred).
- 15+ years of clinical R&D experience in biopharma (or combined clinical/industry experience).
- Direct ADC experience (especially PBD-based or CD19-targeted agents).
Strongly Preferred:
- Clinical experience treating aggressive B-cell lymphomas (DLBCL, HGBCL, transformed FL).
- Familiarity with evolving DLBCL treatment landscape; ability to position ZYNLONTA strategically.