Senior Clinical Development Physician – Contractor

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Act as the medical monitor for ZYNLONTA clinical trials

• Offer immediate clinical insights on patient eligibility, dosage adjustments, premedication adherence, and management of specific toxicities

• Conduct thorough clinical data assessments of patient profiles and additional eCRF information

• Create data inquiries and engage in discussions regarding patient cases with Investigators

• Oversee ongoing assessments of benefits versus risks, including evaluations of SAEs, AESIs, and emerging safety indicators

• Collaborate with Pharmacovigilance, DSMC/iDMC, and Biostatistics for prompt signal identification and risk management

• Work alongside Translational Medicine, Biomarkers, and Biostatistics to analyze patient outcomes

• Contribute to label strategy and lifecycle management

• Ensure that medical monitoring and sBLA procedures adhere to ICH-GCP, FDA/EMA guidelines, and internal standard operating procedures

• Keep audit-ready documentation of clinical decisions and benefit-risk assessments

⛳️ Requirements

• MD degree is required

• MD/PhD is preferred

• Board certification in Hematology/Oncology is preferred, particularly in U.S. clinical settings

• Significant clinical experience in treating aggressive B-cell lymphomas (DLBCL, HGBCL, transformed FL) is strongly preferred

• Over 15 years of clinical R&D experience in biopharma, or a mix of clinical and industry experience

• Direct experience with antibody-drug conjugates (ADCs), especially PBD-based or CD19-targeting agents

• Knowledge of the evolving treatment landscape for DLBCL

• Capability to strategically position ZYNLONTA within the DLBCL treatment framework

🏝️ Benefits

• Flexible work environment

• Approximately 30–40 hours per week of remote work