Executive Director, Early Clinical Development, NHL Program Lead
About The Position
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. 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.
Requirements
- MD, MD-PhD, or equivalent medical degree required; board certification in hematology or oncology is required.
- Minimum of 6 years of clinical development experience in the biopharmaceutical industry and/or academic medicine, with substantial experience in hematologic malignancies; experience in Non-Hodgkin Lymphoma is strongly preferred.
- Demonstrated experience designing and leading early clinical development programs, including first-in-human studies, dose escalation, dose expansion, dose selection, integrated safety monitoring, clinical data review, and proof-of-concept generation.
- Experience with cell therapy, CAR-T, in vivo cell therapy, T-cell engagers, bispecific antibodies, or other immuno-oncology modalities is highly desirable.
- Experience contributing to IND submissions, pre-IND or IND meetings, regulatory briefing packages, and health authority interactions is highly desirable.
- Strong understanding of hematology/oncology clinical trial design, response assessment, safety monitoring, benefit-risk evaluation, dose optimization, biomarker strategy, and clinical development decision-making.
- Experience leading or significantly contributing to cross-functional development teams in a matrixed, global environment is preferred.
- Ability to translate complex medical, scientific, translational, regulatory, and competitive information into clear clinical development strategies and actionable plans.
- Excellent written and verbal communication skills, including experience developing clinical and regulatory documents, presenting to senior leaders, and engaging external experts and investigators.
- Strong collaboration, influencing, conflict-management, negotiation, and decision-making skills, with the ability to align stakeholders across functions, geographies, and levels of the organization.
- Demonstrated ability to anticipate and integrate needs from clinical operations, regulatory, safety/pharmacovigilance, biometrics, translational science, project management, CMC, and other development functions.
- Track record of delivering results in a fast-paced environment, with the ability to operate strategically while contributing hands-on when needed.
- Commitment to the highest standards of quality, ethics, compliance, patient safety, and professional conduct.
- Ability to travel up to 15–20% of the time.
Nice To Haves
- Experience in Non-Hodgkin Lymphoma is strongly preferred.
- Experience with cell therapy, CAR-T, in vivo cell therapy, T-cell engagers, bispecific antibodies, or other immuno-oncology modalities is highly desirable.
- Experience contributing to IND submissions, pre-IND or IND meetings, regulatory briefing packages, and health authority interactions is highly desirable.
- Experience leading or significantly contributing to cross-functional development teams in a matrixed, global environment is preferred.
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 a culture of patient focus, scientific rigor, collaboration, urgency, ethics, compliance, and operational excellence.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
- Flexible spending and health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
