Executive Director, Early Clinical Development, NHL Program Lead

legendcareers; New Jersey; On-site; USD 250,000 - 360,000; Full time

Job summary

Legend Biotech in Somerset, New Jersey seeks an Executive Director, Clinical Development to lead the non-Hodgkin lymphoma program, shaping strategy and executing an integrated clinical development plan across early and later stages.

The role requires deep hematology/oncology expertise, strong leadership in a fast-paced matrixed environment, and collaboration across translational science, regulatory, safety, biostatistics, and clinical operations to deliver high‑quality data for potential

Qualifications

• Experience leading oncology/hematology clinical development programs.
• Proven track record with IND submissions and regulatory interactions.
• Ability to lead cross-functional teams in a matrix environment.

Responsibilities

• Provide strategic and medical leadership for NHL program.
• Develop and execute the integrated clinical development plan for NHL program.
• Lead design and execution of early clinical studies; contribute to late-stage development.
• Collaborate with translational science, regulatory, safety/ PV, biostatistics, data management, and clinical operations.

Skills

Executive Leadership

Hematology Oncology

Clinical Development

IND Submissions

Cross-functional Leadership

Regulatory Strategy

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life‑threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T‑cell (CAR‑T), T‑cell receptor (TCR‑T), natural killer (NK) cell‑based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting‑edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an Executive Director, Clinical Development, to serve as the clinical lead for the Non‑Hodgkin Lymphoma program within the Clinical Development organization. This role will be based in Somerset, New Jersey.

Role Overview

The Executive Director, Clinical Development, will provide strategic, and scientific, and medical leadership for Legend Biotech's non‑Hodgkin Lymphoma clinical development program. This individual will serve as the clinical lead for the program, accountable for developing and shaping the lymphoma strategy and executing an integrated clinical development strategy across early‑stage and, as appropriate, later‑stage development.

The role includes leading first‑in‑human, dose‑escalation, dose‑expansion, and proof‑of‑concept studies. Collaborating on cross‑functional clinical development activities, including supporting the delivery of IND submissions, preparation for and participation in regulatory interactions; integrating translational, biomarker, pharmacology, and safety data, and collaborating on clinical operational inputs. Ultimately the individual will drive the generation of high‑quality clinical data to support clinical benefit‑risk assessment, differentiation, in support of potential registration. The successful candidate will bring deep hematology/oncology expertise, strong judgment, experience needed to advance innovative cell therapies, and the ability to lead effectively in a fast‑paced, highly matrixed and dynamic environment.

Key Responsibilities

• Serve as the clinical lead for the Non‑Hodgkin Lymphoma program, providing strategic, scientific, and medical leadership across the development lifecycle.
• Develop and execute the integrated clinical development plan, including indication strategy, patient population selection, endpoint strategy, dose‑selection rationale, biomarker strategy, safety monitoring approach, and evidence‑generation plan.
• Lead the design, execution, monitoring, interpretation, and reporting of first‑in‑human, dose‑escalation, dose‑expansion, proof‑of‑concept, and other early clinical studies.
• Lead or contribute to late‑stage clinical development activities when appropriate, including pivotal study strategy, protocol design, data interpretation, and registration‑enabling planning.
• Provide clinical leadership for protocols, clinical study reports, investigator brochures, regulatory briefing documents, IND submissions, health authority meeting packages, publications, abstracts, presentations, and other key clinical deliverables.
• Supervision of the NHL clinical development medical director(s) and clinical science team.
• Partner closely with translational science, biomarker, pharmacology, nonclinical, regulatory, safety/pharmacovigilance, biostatistics, data management, clinical operations, project management, CMC, and commercial colleagues to ensure integrated and executable development plans.
• Provide medical and scientific oversight for study conduct, including medical monitoring, eligibility review, safety review, dose‑escalation decision‑making, data review, and interpretation of emerging clinical data.
• Ensure early development plans reflect contemporary regulatory expectations for oncology drug development, including robust dose optimization, PK/PD integration, biomarker‑informed decision‑making, and clear benefit‑risk assessment.
• Engage with investigators, academic experts, cooperative groups, study sites, and external advisors to support high‑quality execution, scientific exchange, enrollment strategy, and program visibility.
• Represent the NHL program in internal governance forums, senior leadership reviews, external scientific meetings, regulatory interactions, and business development or partnership discussions as needed.
• Identify key program risks and mitigation strategies, including clinical, regulatory, operational, safety, competitive, and translational risks.
• Champion