Legend Biotech US
Sr. Medical Director, Drug Safety and Pharmacovigilance
Legend Biotech US, Trenton, New Jersey, United States
Sr. Medical Director, Drug Safety and Pharmacovigilance
Somerset, New Jersey, United States 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. 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, Drug Safety & Pharmacovigilance
as part of the
Clinical Development Team
working in
Somerset, NJ. 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. Key Responsibilities Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals. Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information. Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Medical safety review including causality assessment of all available safety data generated from various sources. Provides medical expert safety review input into all critical documents for products in clinical development. Identification and management of Urgent Safety Measures with support of cross functional team. Overview, and/or author aggregate reports and signal evaluation reports for assigned projects. Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics. Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Oversee and manage internal safety scientist and safety operation team. Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws. Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses. Lead high quality planning and execution of external meetings and internal stakeholder meetings. Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Identify project risks with input from the cross functional teams, and support resolving issues. Prepare/oversee monthly progress reports and ad-hoc reports as required. Support process improvement and functional training at departmental & company level. Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork. Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations. Requirements MD or MBBS or MD-PhD or equivalent medical degree. 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance. Strong understanding of pharmacovigilance regulations in the US and EU. Experience in supporting drug safety activities in registrational clinical studies. High level of medical competence, with an ability to balance this with industry standards to achieve business goals. Demonstrated skills in scientific analysis and reasoning. Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance. Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable. Strong track record of delivering results through effective team and peer leadership in matrix. Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity. Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. Experience in biotech - preferred but not required. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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Somerset, New Jersey, United States 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. 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, Drug Safety & Pharmacovigilance
as part of the
Clinical Development Team
working in
Somerset, NJ. 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. Key Responsibilities Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals. Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information. Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Medical safety review including causality assessment of all available safety data generated from various sources. Provides medical expert safety review input into all critical documents for products in clinical development. Identification and management of Urgent Safety Measures with support of cross functional team. Overview, and/or author aggregate reports and signal evaluation reports for assigned projects. Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics. Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Oversee and manage internal safety scientist and safety operation team. Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws. Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses. Lead high quality planning and execution of external meetings and internal stakeholder meetings. Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Identify project risks with input from the cross functional teams, and support resolving issues. Prepare/oversee monthly progress reports and ad-hoc reports as required. Support process improvement and functional training at departmental & company level. Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork. Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations. Requirements MD or MBBS or MD-PhD or equivalent medical degree. 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance. Strong understanding of pharmacovigilance regulations in the US and EU. Experience in supporting drug safety activities in registrational clinical studies. High level of medical competence, with an ability to balance this with industry standards to achieve business goals. Demonstrated skills in scientific analysis and reasoning. Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance. Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable. Strong track record of delivering results through effective team and peer leadership in matrix. Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity. Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. Experience in biotech - preferred but not required. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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