ADC Therapeutics

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 Medical Director, Global Pharmacovigilance

Director

• 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

Senior Medical Director, Global Pharmacovigilance

Director, Pharmacovigilance Scientist