ADC Therapeutics

Operations

• Accountable for delivery of PV operation activities and ensuring timely and consistent execution globally
• Manage and oversee PV vendor responsible for ICSR management (collection, processing, and regulatory reporting) including associated quality and training activities
• Collaborate closely with stakeholders including PV partners (PVPs) to ensure operational deliverables are met
• Ensure regulatory compliance with global regulatory authorities and submission compliance with PVPs
• Provide vigilance expertise on operational processes to stakeholders (clinical development, clinical science, biometrics, data management, commercial)
• Implement and maintain the PV QMS and ensure adherence to SOPs and best industry practices
• Work with Quality Management personnel on PV QMS to develop or update PV SOPs/WI
• Ensure awareness and training of Company personnel and external groups on PV principles, policies and SOPs
• Lead, develop, negotiate, implement and maintain safety agreements (PVAs, SDEAs, SMPs) with PVPs and IITs
• Drive and set safety performance standards within PV operations to ensure quality and compliance
• Monitor vendor KPI, compliance metrics, invoice management, budget and quality standards for PV operations deliverables
• Develop and implement operational sourcing strategies to optimize cost, capacity, quality and performance
• Support audits & inspections, preparation of audit strategy, root cause analysis and CAPA development
• Support/lead aggregate reports, signal and risk management activities and collaborate with safety physician on signal detection
• Support preparation, quality control and compliance of aggregate safety reports (PBRER, DSUR, SASUSAR), REMS, RMPs, risk communications and regulatory responses
• Collaborate with vendor, PVP and Regulatory to develop submission schedules for aggregate safety reports and regulatory submissions
• Support preparation and review of safety sections of IB, protocols, informed consent forms, SAPs, clinical study reports, IND/NDA/BLA/MAA and renewals
• Participate in investigator meetings to train site personnel in SAE data collection and reporting
• Support safety physician in iDMC meetings and ensure safety data reconciliation between safety and clinical databases

Senior Director, Global PV Operations and Safety Science

Director

• Lead and manage a team of 2 Hematology Therapeutic Specialists focused on community pull-through
• Report to the Sr Area Business Director and serve as player/coach for area business
• Establish partnership with key stakeholders within accounts and serve as the single-point of contact within the account for ADC Therapeutics
• Develop robust account plans for each key account and collaborate across the organization to execute on plans
• Develop an understanding of accounts and perception/sentiment towards ZYNLONTA
• Be an expert on the clinical profile of ZYNLONYA and clearly articulate the value proposition to key stakeholders
• Utilize approved materials and resources to drive awareness and advocacy for ZYNLONTA
• Understand mapping of physicians and key stakeholders within each account to best drive advocacy for ZYNLONTA
• Partner with appropriate stakeholders within accounts to ensure a positive experience with ZYNLONTA including office staff, pharmacists, business managers, etc., and triaging requests compliantly
• Participate in account reviews and business reviews with the cross-functional ADCT team
• Manage region strategy and execution for Southern California with geographic center of Los Angeles

Associate Director, Strategic Accounts

• Develops and maintains an understanding of the safety profile of their assigned product(s)
• Supports product safety surveillance activities for assigned product(s) during all phases of the product life cycle
• Leads Safety Scientist activities of cross-functional project teams for developmental compounds and/or marketed products.
• Responsible for individual and aggregate case reporting activities including ICSR case management and aggregate reporting.
• Works in collaboration with the Sr Medical Director to develop, maintain, oversee, and execute comprehensive safety surveillance.
• Conduct signal detection, (including adverse event data, literature, and other sources) in collaboration with Sr Medical Director and according to ADCT’s Signal Management and Safety Governance process, and management activities including but not limited to maintenance of signal tracker, authoring safety topic reviews for signals or issues including PQC or in response to Regulatory Authority requests.
• Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports, safety management plans.
• Participate in and provide input for iDMC or internal monitoring committee meetings as applicable
• Leads the collaboration with Sr Medical Director and Clinical representatives and authors the Reference Safety Information (RSI) for assigned products.
• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
• Authors/provide strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the Sr Medical Director and other functional experts.
• Contributes to pharmacovigilance and risk management planning and activities for ADCT products, including preparation and maintenance of CCDS, labeling documents Risk Management Plans with the applicable License Partners as appropriate, REMS if applicable and risk communications
• Supports multidisciplinary SMT/JSMT and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the Sr Medical Director.
• Take on the responsibility for appropriate specialized roles within PV. This may include but not limited to:
o Provide vigilance expertise on operational processes to stakeholders
o Work in close collaboration with QA to ensure up-to-date processes and procedures for operational activities in the end-to-end safety process, including ICSR process, aggregate reports, Safety agreement, Safety Regulatory report processes.
o Establish, negotiate, implement and maintain safety agreements (SDEA, PVAs, SMPs)
o Provide vendor oversight and achieve defined performance metrics for patient safety operations process.
o Ensure Patient Safety (including Safety Operations) function is inspection ready, assisting PV function and quality personnel during inspections and audits
o Drive PS performance standards towards quality, inbound and outbound compliance
o Establish and implement best practice sharing in PV activities

Director, Pharmacovigilance Scientist

Medical Director

• The Senior Medical Director will serve as the safety strategy leader involved in safety related and benefit-risk decision making activities for assigned product(s) at ADC Therapeutics (ADCT).
• The successful candidate will have demonstrated prior career success as a product safety physician and managing the medical safety strategy for products in development and post-marketing, as well as effectively engaged and influenced multiple cross functional teams including but not limited to Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, Affiliates and External Service providers as appropriate.
• The Senior Medical Director plays a lead role in owning, shaping and planning the safety strategy and activities for their assigned product(s). This would include acting as the lead point of contact for safety with cross functional leaders, defining long term safety related objectives, ability to articulate the overall design and the requirement of their defined safety strategy in the context of the overall clinical development program (e.g., TPP, CDP) and or post-marketing requirements.
• This role is accountable for the safety profile, product specific patient risk management strategies and activities and ensure safety communications approaches are implemented and can be demonstrated to be effective.
• The Senior Medical Director role is pivotal to the overall success of the product(s) they are assigned to. They are empowered to work independently under the oversight of VP, Global PV.
• Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders both verbally and in writing.
• The individual who assumes this position will interact with multiple levels of management within ADCT external stakeholders in the medical community, as well as with global regulatory authorities.
• There is a preference for this role to be based near our office and have the ability to travel to the New Providence, NJ office as needed for business meetings. However, there is no in-office requirements and the role can be done remotely.

Senior Director, Global PV Operations and Safety Science

Associate Director, Strategic Accounts

Director, Pharmacovigilance Scientist

Senior Medical Director, Global Pharmacovigilance