Sr. Medical Director, Late Clinical Development

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 Sr. Medical Director, Late Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The (Sr.) Medical Director of Late 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 a Late Clinical Development study, and other projects as assigned, working closely with partners in Pre-Clinical, Regulatory, Safety, Medical Affairs, Translational Development, Commercial & Biostatistics. Full understanding of tenets of GCP 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 late-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.
• Medical review of clinical data including query generation and resolution.
• Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for collaboration with alliance partner, business development and other 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. US board certification in hematology and/or oncology is highly desirable.
• 1+ / 3+ (Senior) 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 in clinical development including the design and execution of registrational studies. Experience in submission of BLAs is highly desirable.
• Experience leading 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 biostatistics, regulatory, clinical operations, development sciences, pharmacovigilance, and other functional needs to ensure successful program delivery.
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project manage