Vice President, Global Drug Safety
ADC Therapeutics, New Providence, NJ, United States
Overview
Transforming Cancer Therapy Together. At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients lives. What You’ll Do Position Overview This position will be accountable for all activities and deliverables of the Drug Safety function, providing operational and medical oversight of safety activities for all ADCT medicinal products administered to humans and ensuring regulatory requirements are met. The incumbent will be the key driver of risk management strategies for all drugs in development and post‑approval, and ensure establishment and maintenance of core safety information during each products lifecycle. The individual will supervise and mentor Drug Safety Department staff and collaborate with other department heads within Development, team leaders, and other relevant functions. The incumbent will also provide quality oversight to safety service providers and oversee safety data exchanges with license partners. This role reports to the Chief Medical Officer and is based in the New Providence, NJ office with a hybrid schedule; remote work is possible with occasional in-office needs.
Job Responsibilities Oversee receipt, processing, review, reporting, and follow-up of adverse events and company medical assessment of individual cases Oversee review, interpretation, and summarization of aggregate safety data from all sources and determine potential impact on planned and ongoing clinical programs and post‑approval use Oversee signal management system including signal detection, evaluation, and management Serve as the senior safety advisor on relevant project/product core teams Oversee assessment and update of the safety profile of ADCTs compounds, including safety labeling updates in collaboration with regulatory affairs Oversee safety data exchange with partners Collaborate with clinical development and medical affairs on safety sections in documents such as IBs, clinical trial reports, IND annual reports, regulatory materials, DSMB/advisory board materials, and scientific publications Oversee PV quality system and ensure adherence to SOPs, policies, regulations, and laws as applicable Provide quality oversight on safety service providers work including safety database hosting Lead, guide, and develop direct reports; set performance standards and manage performance Collaborate effectively with cross-functional departments Ensure effective departmental resource planning and sound operational execution Work closely with Business Development on safety data disclosure for partnering opportunities Qualifications Who You Are MD required 7 years of clinical development experience including 4 years direct involvement in drug safety/pharmacovigilance Deep knowledge of drug safety/pharmacovigilance practices Expertise in generation of periodic reports and providing safety input on Clinical Study Protocols, IBs, and Study Reports for products in development for regulatory approval, DSUR, PADER, and PBRER Proficient in drug safety regulations domestically and internationally, including GVP/GCP/ICH guidelines Technical knowledge of drug safety databases, MedDRA, and WHO Drug coding Experience with vendor oversight and management Clinical and analytical knowledge in relevant therapeutic areas Strong organizational and management skills Effective communicator with strong verbal and written skills Leads with influence and builds strong team morale Ability to think creatively and execute in a fast-paced environment Domestic travel up to 10% ADC Therapeutics is an Equal Employment Opportunity (EEO) employer. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
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Transforming Cancer Therapy Together. At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients lives. What You’ll Do Position Overview This position will be accountable for all activities and deliverables of the Drug Safety function, providing operational and medical oversight of safety activities for all ADCT medicinal products administered to humans and ensuring regulatory requirements are met. The incumbent will be the key driver of risk management strategies for all drugs in development and post‑approval, and ensure establishment and maintenance of core safety information during each products lifecycle. The individual will supervise and mentor Drug Safety Department staff and collaborate with other department heads within Development, team leaders, and other relevant functions. The incumbent will also provide quality oversight to safety service providers and oversee safety data exchanges with license partners. This role reports to the Chief Medical Officer and is based in the New Providence, NJ office with a hybrid schedule; remote work is possible with occasional in-office needs.
Job Responsibilities Oversee receipt, processing, review, reporting, and follow-up of adverse events and company medical assessment of individual cases Oversee review, interpretation, and summarization of aggregate safety data from all sources and determine potential impact on planned and ongoing clinical programs and post‑approval use Oversee signal management system including signal detection, evaluation, and management Serve as the senior safety advisor on relevant project/product core teams Oversee assessment and update of the safety profile of ADCTs compounds, including safety labeling updates in collaboration with regulatory affairs Oversee safety data exchange with partners Collaborate with clinical development and medical affairs on safety sections in documents such as IBs, clinical trial reports, IND annual reports, regulatory materials, DSMB/advisory board materials, and scientific publications Oversee PV quality system and ensure adherence to SOPs, policies, regulations, and laws as applicable Provide quality oversight on safety service providers work including safety database hosting Lead, guide, and develop direct reports; set performance standards and manage performance Collaborate effectively with cross-functional departments Ensure effective departmental resource planning and sound operational execution Work closely with Business Development on safety data disclosure for partnering opportunities Qualifications Who You Are MD required 7 years of clinical development experience including 4 years direct involvement in drug safety/pharmacovigilance Deep knowledge of drug safety/pharmacovigilance practices Expertise in generation of periodic reports and providing safety input on Clinical Study Protocols, IBs, and Study Reports for products in development for regulatory approval, DSUR, PADER, and PBRER Proficient in drug safety regulations domestically and internationally, including GVP/GCP/ICH guidelines Technical knowledge of drug safety databases, MedDRA, and WHO Drug coding Experience with vendor oversight and management Clinical and analytical knowledge in relevant therapeutic areas Strong organizational and management skills Effective communicator with strong verbal and written skills Leads with influence and builds strong team morale Ability to think creatively and execute in a fast-paced environment Domestic travel up to 10% ADC Therapeutics is an Equal Employment Opportunity (EEO) employer. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
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