Senior Clinical Development Physician (Contractor)

Posted 24 Days Ago
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New Providence, NJ, USA
In-Office
Senior level
Biotech • Pharmaceutical
The Role
Provides senior clinical leadership for the ZYNLONTA program, serving as medical monitor, overseeing patient safety and benefit-risk assessments, leading sBLA authoring and FDA interactions, and supporting regulatory strategy. Partners with cross-functional teams on biomarker and subgroup analyses, KOL engagement, clinical congresses, mentoring, compliance, and inspection readiness for lymphoma studies.
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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.

The Senior Clinical Development Physician Contractor for the ZYNLONTA Program will work approximately 30-40 hours per week remotely (with a preference for New Jersey/East Coast based). 

Key Responsibilities:

Medical Monitoring & Patient Safety Oversight — ZYNLONTA Program 

  • Serve as the medical monitor for ZYNLONTA 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 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.

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 (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 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. 

Skills Required

  • MD degree
  • MD/PhD degree
  • Board certification in Hematology/Oncology
  • Clinical experience treating aggressive B-cell lymphomas, including DLBCL, HGBCL, or transformed FL
  • 15+ years of clinical R&D experience in biopharma
  • Authorship on at least one successful BLA, sBLA, NDA, or sNDA submission in hematologic malignancies, or equivalent combined clinical and industry experience
  • Direct experience with antibody-drug conjugates, particularly PBD-based or CD19-targeted agents
  • Demonstrated FDA interaction experience, including Type B/C meetings, pre-sBLA meetings, or Advisory Committees
  • Familiarity with the 2L+ relapsed/refractory DLBCL treatment landscape, including CAR-T, bispecifics, Pola-R-CHP, and loncastuximab combinations
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The Company

What We Do

ADC Therapeutics is a commercial-stage global leader and pioneer in the field of antibody-drug conjugates (ADCs). The company is dedicated to transforming the lives of those impacted by cancer by developing innovative treatments, such as ZYNLONTA, aimed at treating relapsed or refractory diffuse large B-cell lymphoma and other hematologic malignancies.

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