Job Description

Overview Senior Director, Global PV Operations & Safety Science role at ADC Therapeutics . Remote-based; affiliated with the New Providence, New Jersey office. Travel to the office and other locations as needed for meetings and business requirements. Join to apply for the Senior Director, Global PV Operations & Safety Science role at ADC Therapeutics . Job responsibilities Accountable for delivery of PV operations activities and ensuring timely and consistent global execution. Manage and oversee PV vendor responsible for ICSR management (collection, processing, and regulatory reporting) including related quality and training to meet standards and timelines for the product portfolio. Collaborate with PV partners to ensure operational deliverables are met and to identify opportunities for efficiency and excellence. Ensure regulatory compliance with global authorities and submission compliance with PVPs. Provide vigilance expertise on operational processes to stakeholders including clinical development, clinical science, biometrics, data management, and commercial teams. Implement and maintain the PV Quality Management System (QMS) and ensure adherence to SOPs and best industry practices. Develop and update PV SOPs/WIs in collaboration with Quality Management to maintain end-to-end safety processes, including ICSR management, regulatory reporting, safety agreements, signal and risk management. Ensure awareness and training of PV principles, policies, and SOPs for appropriate personnel and external groups. Lead, negotiate, implement, and maintain safety agreements (PVAs, SDEAs, SMPs) with PV partners and IITs. Drive safety performance standards within PV operations to ensure quality and compliance. Monitor tasks to meet global regulatory requirements and internal standards; oversee KPI, compliance metrics, invoice management, budget, and quality for PV operations. Develop and implement operational sourcing strategies to optimize cost, capacity, quality, and performance by balancing internal and external resources. Prepare PV operations and PS&PV function for audits/inspections; support audit strategy, root cause analysis, and CAPA development. Lead aggregate reports, signal and risk management activities; support the safety physician on signal detection, data collection, analysis, and reporting; coordinate signal detection meetings and documentation. Support safety signal detection documentation activities including validation and tracking of signal and HA safety commitments. Contribute to strategy and review of safety assessments and drug safety reports for signals or issues; collaborate with PV Partners to ensure safety risk management requirements are met. Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, SASUSAR); coordinate submission schedules along with vendors and Regulatory teams. Provide scientific and safety support for preparation, quality control, and compliance of Benefit-Risk and aggregate safety reports (DSUR, PBRER, RMPs, REMS, risk communications) and related regulatory responses. Assist with documentation, version control, and stakeholder coordination for CCSI or potential safety variations as part of safety governance. Contribute to clinical study management from a safety perspective, including safety sections of regulatory documents and participation in investigator meetings as required. Support safety data reconciliation between safety and clinical databases via vendor coordination. Requirements Bachelor’s Degree in healthcare or a PhD in biomedical/pharmaceutical sciences; RN or PharmD preferred. Extensive drug safety experience in oncology is highly desirable. Minimum 10 years of PV operations experience in biotechnology or pharmaceutical industry. Management experience with direct reports preferred. High emotional intelligence with a proven ability to foster a positive PV culture. Expert knowledge of global PV requirements (e.g., CFR, GVP, ICH Guidelines). Experience with MedDRA and proprietary safety databases; experience managing CRO/vendor relationships. Experience with Quality Management Systems (QMS) and SOP development. Extensive PV process knowledge for individual case safety review, signal detection and evaluation, risk management, aggregate data assembly, and safety reporting; clinical study safety management experience. Experience with DSURs, IBs, PBRERs/PADERs, regulatory responses, and safety labeling; audit and inspection experience. Strong relationship-building and cross-functional collaboration skills in a multi-site, diverse organization. Proficiency in Microsoft Office; strong strategic thinking, organizational, analytical, project management, verbal and written communication skills. Join Our Inclusive Team ADC Therapeutics is an Affirmative Action/EEO employer. EOE minorities/females/protected veterans/disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success. #J-18808-Ljbffr ADC Therapeutics

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