[Hiring] Senior Clinical Development Physician @ADC Therapeutics America Inc

Role 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.

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).
  • 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).
  • 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.
  • 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.
  • Inform 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.

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.

Requirements

• 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.