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 develop 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.
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
Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals.
Conduct signal detection activities, including monitoring, evaluation, interpretation, management and communication of safety information.
Conduct Safety Monitoring Team (SMT) meetings to evaluate risk‑benefit for the compounds with support from cross‑functional teams, escalating and presenting unresolved safety issues to senior management in company governance meetings.
Perform medical safety review including causality assessment of all available safety data from various sources (pre‑clinical, clinical trial data, post‑marketing and literature) throughout the development process for assigned compounds/projects.
Provide medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)).
Identify and manage Urgent Safety Measures with support of cross‑functional team.
Author aggregate reports and signal evaluation reports for assigned projects.
Respond to regulatory authorities on safety topics and provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services and vendor oversight.
Oversee and manage internal safety scientist and safety operation team.
Assist with the writing and development of SOPs to ensure compliance with regulations and local laws while maintaining clear instructions for procedures and activities to achieve company goals.
Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses.
Plan and execute high quality external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.).
Build effective working relationships, influence, negotiate, and drive organizational engagement; adapt quickly to changing needs.
Identify project risks with input from cross‑functional teams, support resolution of issues, and ensure potential delays are fully mitigated.
Prepare and oversee monthly progress reports and ad‑hoc reports as required.
Support process improvement and functional training at departmental & company level.
Demonstrate highest quality, ethical & professional values in all aspects of teamwork.
Ensure compliance with corporate policies, procedures, and 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 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 matrixed environments.
Experience managing team activities; coaching, mentoring, training team; leading performance management activity (goal setting, performance appraisals, etc.).
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.
The anticipated base pay range is $285,906 - $375,253 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k) retirement plan with company match that vests fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs – demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug‑free workplace.
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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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.
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
Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals.
Conduct signal detection activities, including monitoring, evaluation, interpretation, management and communication of safety information.
Conduct Safety Monitoring Team (SMT) meetings to evaluate risk‑benefit for the compounds with support from cross‑functional teams, escalating and presenting unresolved safety issues to senior management in company governance meetings.
Perform medical safety review including causality assessment of all available safety data from various sources (pre‑clinical, clinical trial data, post‑marketing and literature) throughout the development process for assigned compounds/projects.
Provide medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)).
Identify and manage Urgent Safety Measures with support of cross‑functional team.
Author aggregate reports and signal evaluation reports for assigned projects.
Respond to regulatory authorities on safety topics and provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services and vendor oversight.
Oversee and manage internal safety scientist and safety operation team.
Assist with the writing and development of SOPs to ensure compliance with regulations and local laws while maintaining clear instructions for procedures and activities to achieve company goals.
Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses.
Plan and execute high quality external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.).
Build effective working relationships, influence, negotiate, and drive organizational engagement; adapt quickly to changing needs.
Identify project risks with input from cross‑functional teams, support resolution of issues, and ensure potential delays are fully mitigated.
Prepare and oversee monthly progress reports and ad‑hoc reports as required.
Support process improvement and functional training at departmental & company level.
Demonstrate highest quality, ethical & professional values in all aspects of teamwork.
Ensure compliance with corporate policies, procedures, and 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 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 matrixed environments.
Experience managing team activities; coaching, mentoring, training team; leading performance management activity (goal setting, performance appraisals, etc.).
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.
The anticipated base pay range is $285,906 - $375,253 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k) retirement plan with company match that vests fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs – demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug‑free workplace.
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