Job Description
Sr. Medical Director - Drug Safety and Pharmacovigilance (Remote)
United States
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Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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, Drug Safety Pharmacovigilance as part of the Clinical Development Team working remotely in the US.
Role Overview
The Sr. Medical Director, Drug Safety Pharmacovigilance is a critical role in the company with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency alignment across studies, working closely with cross functional teams for achieving project goals, within timelines with high quality.
Key Responsibilities
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