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. Legend Biotech is seeking a Sr.

Medical Director / Executive Director, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ. Role Overview The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects .

The candidate for this role will be responsible to lead the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. g. ) and the relevant compliance framework for clinical development activities are essential.

Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials. Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy. Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.

Collaborate with academic scientists, clinical experts, and study investigators. Represent and advocate for the project in internal and external venues. Clinical leadership for business development and partnership activities as needed.

Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology. 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required. Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.

Experience in biotech - preferred but not required. Demonstrated capacity to think creatively when addressing complex situations Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs. Experience leading pre-IND and IND meetings with health authorities is highly desirable.

Sr. Medical Director/Executive Director, Early Clinical Development