Sr. Medical Director, Drug Safety and Pharmacovigilance

<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.</span></p> <p style="line-height: 1.2;"> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"> </p></div><div class="col-xs-12 no-horiz-padding"><hr> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>Sr. Medical Director, Drug Safety Pharmacovigilance </strong>as part of the <strong>Clinical Development Team </strong>working in <strong>Somerset, NJ. </strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong> </span></p> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.</span></li> <li><span style="font-family: arial, helv ... (truncated, view full listing at source)