Executive Director, Pipeline Clinical Lead

Legend Biotech

Somerset, New Jersey, United StatesPosted 18d ago

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Job description

<div class="content-intro">Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.   Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.  </div>Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ. Role Overview The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions. The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential. This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact. Key Responsibilities Clinical Development Leadership <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide clinical input into asset selection, review of preclinical data, and development path decisions.</li> </ul> Regulatory & Compliance <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.</li> </ul> Cross Functional & External Collaboration <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with external development partners, academic investigators, KOLs, and study sites.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Act as a credible scientific and clinical representative for programs in internal governance and external forums.</li> </ul> People & Matrix Leadership <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Contribute clinical leadership to business development, due diligence, and partnership activities when required.</li> </ul> Requirements <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">MD or MD PhD (or equivalent) with US board certification or international equivalent.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proven experience designing and executing clinical trials from first in human through registrational stages.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Hands on, execution oriented minds

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