Executive Director, Early Clinical Development

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, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ. Role Overview The 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. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc.) 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. 6+ 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. Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery Ability to communicate effectively with cross f…