Legend Biotech Corporation

Executive Director, Early Clinical Development, NHL Program Lead

Legend Biotech Corporation$338K — $444K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • MD, MD-PhD, or equivalent medical degree required; board certification in hematology or oncology necessary.
  • Minimum 6 years of clinical development experience in biopharmaceuticals or academic medicine, focusing on hematologic malignancies.
  • Proven experience in leading early clinical development programs, including first-in-human studies.
  • Familiarity with cell therapies, CAR-T, and other immuno-oncology modalities preferred.
  • Experience with IND submissions and regulatory interactions is desirable.
  • Strong grasp of oncology clinical trial design and benefit-risk evaluation essential.
  • Exceptional communication and collaboration skills are required.

Responsibilities

  • Lead the Non-Hodgkin Lymphoma program with strategic and clinical oversight across the development lifecycle.
  • Develop and oversee the clinical development plan including patient selection and safety monitoring.
  • Design and execute first-in-human, dose-escalation, and proof-of-concept studies.
  • Provide clinical guidance for regulatory documents and study reports.
  • Supervise the NHL clinical development team and partner with cross-functional departments.
  • Ensure alignment with contemporary regulatory standards for oncology development.
  • Identify and mitigate key clinical and operational risks.

Benefits

  • Medical, dental, and vision insurance.
  • 401(k) retirement plan with immediate vesting company match.
  • Eight weeks of paid parental leave after three months of employment.
  • Generous paid time off policy including vacation, personal, and sick time.
  • Voluntary benefits such as flexible spending and health savings accounts.
  • Well-being initiatives and peer recognition programs.
Full Job Description
Executive Director, Early Clinical Development, NHL Program Lead 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 a culture of patient focus, scientific rigor, collaboration, urgency, ethics, compliance, and operational excellence. 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. #Li-AS1 #Li-Hybrid The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Pay Range (Base Pay): $338,656-$444,486 USD Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

About Legend Biotech Corporation

Legend Biotech Corporation is a clinical-stage biopharmaceutical company focused on developing innovative cell therapies for cancer. The company's lead product candidate, LCAR-B38M/JNJ-68284528, is a chimeric antigen receptor (CAR) T-cell therapy that is being developed for the treatment of multiple myeloma, a type of blood cancer. Legend Biotech was founded in 2014 as a subsidiary of GenScript Biotech Corporation and became an independent company in 2019. The company is headquartered in Shanghai, China and has operations in the United States and Europe.
Learn more about Legend Biotech Corporation
Size
1,071 employees
Market Cap
$8.2 billion
Industry
NASDAQ

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