Senior Clinical Development Physician (Contractor)

Description

Transforming Cancer Therapy Together

At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives. 

ADC Therapeutics

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization.  Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission.  ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use. 

We are a team of approximately 150 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients.  If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey!  To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.

Key Responsibilities:

Medical Monitoring & Patient Safety Oversight — ZYNLONTA Program 

• Serve as the primary medical monitor for pivotal and supportive ZYNLONTA studies (e.g., LOTIS-5, LOTIS-7, and ongoing combination trials), 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). 
• Lead ongoing benefit-risk assessment across the DLBCL portfolio, 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 in the 2L+ R/R DLBCL population. 

sBLA Authoring & Regulatory Submission Leadership

• Provide clinical leadership for the ZYNLONTA sBLA seeking expanded indication in earlier lines of DLBCL therapy, including authorship and scientific ownership of the Clinical Overview (Module 2.5), Summary of Clinical Efficacy (2.7.3), Summary of Clinical Safety (2.7.4), and integrated summaries (ISE/ISS) bridging LOTIS-2 (accelerated approval), LOTIS-5 (confirmatory), and supportive studies. 
• Drive clinical responses to FDA Information Requests, prepare content for Mid-Cycle/Late-Cycle communications, and serve as a clinical spokesperson for potential ODAC preparation, label negotiations, and post-marketing commitments (including confirmatory and pediatric study obligations). 

Cross-Functional & Strategic Leadership Partner

• Partner with Translational Medicine, Biomarkers, and Biostatistics to characterize patient subgroups associated with best and poorest outcomes on ZYNLONTA (including by COO/GCB vs. non-GCB, double/triple-hit status, prior CAR-T exposure, and age/frailty), informing label strategy and lifecycle planning. 
• Represent ADC Therapeutics in KOL engagements, investigator meetings, and major hematology congresses (ASH, ASCO, EHA, ICML); mentor junior medical monitors and clinical scientists across the DLBCL franchise. 

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. 

Requirements

Minimum 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, including demonstrated authorship on at least one successful BLA/sBLA or NDA/sNDA submission in hematologic malignancies (or a combination of clinical and industry experience)
• Direct experience with antibody-drug conjugates (ADCs) — particularly PBD-based or CD19-targeted agents — and proven track record of substantive FDA interaction (Type B/C meetings, pre-sBLA, Advisory Committees). 
• Familiarity with the evolving 2L+ R/R DLBCL treatment landscape (CAR-T, bispecifics, Pola-R-CHP, Lonca combinations) and ability to position ZYNLONTA strategically within it. 

Join Our Inclusive Team

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.