Job Title: Director, Pharmacovigilance Scientist Job Location: New Providence, NJ, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Director Description

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

Why ADC Therapeutics

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA, ADC Therapeutics has a PSMA-targeting ADC in ongoing development.

We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.

What You’ll Do:

Position Overview

We are looking for a Director, Pharmacovigilance Scientist, to join ADCT in our Global Pharmacovigilance function. In this exciting and challenging role, you will work collaboratively with the Sr Medical Director, PV partners and vendors who provide PV services. You will provide safety science and pharmacovigilance support and play a role supporting the safety strategy and requirements for your assigned drug product(s). You are responsible for all aspects of safety science/PV.

Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across ADCT, including counterparts within Clinical Project Teams, Regulatory Affairs, and Commercial teams.

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. This position reports to the VP, Global Pharmacovigilance.

Main Responsibilities

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: Provide vigilance expertise on operational processes to stakeholders 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. Establish, negotiate, implement and maintain safety agreements (SDEA, PVAs, SMPs) Provide vendor oversight and achieve defined performance metrics for patient safety operations process. Ensure Patient Safety (including Safety Operations) function is inspection ready, assisting PV function and quality personnel during inspections and audits Drive PS performance standards towards quality, inbound and outbound compliance Establish and implement best practice sharing in PV activities

Requirements

Who You Are:

Bachelor’s in sciences/pharmacy/nursing degree or related field however RN, R.Ph., or Pharm D. degree is highly preferred. 10+ years of proven pharmacovigilance experience, preferably in oncology Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas: Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning) Post-Marketing Surveillance (including signal detection & evaluation) MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document) Periodic Safety Reports (deliver strategy, preparation and authoring) Risk Management Plans (deliver strategy, preparation and authoring) Safety governance board interactions and communication across a range of activities Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues Ability to work effectively in an advanced matrix structure Proficient in expressive and receptive communications in English language Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI Skilled in signal detection process and managing safety information from clinical development and post-marketing sources Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management Knowledge of drug development process, pharmacovigilance databases and MedDRA coding Experience with use of safety databases, preferably Argus Safety Database Documented experience in multiple trials with safety inputs at the Global level International experience from a similar role with internal and external stakeholders Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members. Expert level proficiency in reporting and data analysis tools, including Excel

Join Our Inclusive Team

ADC Therapeutics is proud to be 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.

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