Vice President- Global Drug Safety at ADC Therapeutics

WFH Flexible
• New Providence, NJJob TypeFull-timeDescriptionPosition: Vice President-Global Drug SafetyLocation: Hybrid/Remote (New Providence, NJ)Transforming Cancer Therapy TogetherAt 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.Why ADC Therapeutics?ADC Therapeutics (NYSE) is a global leader and pioneer in the field of antibody-drug conjugates (ADCs)
We are experts in the lifecycle of ADCs, from discovery to commercialization. Our CD-19-directed ADC for relapsed/refractory large B-cell lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl), has been approved in the United States and the European Union
We are also exploring its potential in combination with other anti-cancer therapeutics to treat a broader range of patients with DLBCL and other indolent lymphomas. Beyond hematology, our innovative technology toolbox and robust pipeline of ADCs which we are pursuing in solid tumor cancers set us apart. With close to 300 patient-focused, purpose-driven employees, we offer a flexible work environment where you can thrive
If you're passionate about making a global impact, join us on our journey!To learn more about ADC Therapeutics, please visit us at and follow us on  LinkedIn.What You’ll Do:Position OverviewThis person will be accountable for all of the activities and deliverables of the Drug Safety Department on a daily basis including providing operational and medical oversight of safety activities for all ADCT’s 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 product’s lifecycle
The individual will supervise and mentor the Drug Safety Department staff and effectively 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 out of the New Providence, NJ office with the ability to work a hybrid schedule. Job ResponsibilitiesOversees receipt, processing, review, reporting, follow-up of adverse events and company medical assessment of individual casesOversees the review, interpretation and summarization of aggregate safety data from all sources and determine their potential impact on planned and ongoing clinical programs and post approval useOversees signal management system including signal detection, evaluation and managementServe as the senior safety advisor on relevant project /product core teamsOversees assessment and update of the safety profile of ADCT’s compounds including safety labeling update in collaboration with regulatory affairsOversees safety data exchange with PartnersCollaborates with the clinical development and medical affairs team in the compilation of safety sections in documents such as but not limited to IBs, clinical trial reports, IND annual reports, ad-hoc materials for regulatory consultation, DSMB meetings and advisory board meetings, scientific publication, etc. Oversees PV quality system, and ensures adherence to SOPs, policies, regulations and laws as applicableProvides quality oversight on safety service providers’ work including safety database hostingLeads, guides and develops direct reports; sets performance standards and responsible for performance managementDemonstrates the ability to deal effectively and collaboratively with relevant cross-functional departmentsAccountable for effective departmental resource planning and sound operational executionWorks closely with the Business Development department on safety data disclosure for partnering opportunitiesRequirementsWho You Are:MD required7 years of clinical development experience including 4 years’ direct involvement in drug safety/pharmacovigilance activitiesIn-depth knowledge of best drug safety/pharmacovigilance practicesExpert knowledge in generation of periodic reports and in providing safety input on Clinical Study Protocols, IBs and Study Reports for products in development intended for regulatory approval, DSUR, PADER and PBRERProficient in drug safety regulations domestically and preferably internationally including relevant GVP/GCP/ICH guidelinesTechnical knowledge of commercial drug safety databases, MedDRA and WHO Drug codingExperience with vendor oversight and management Clinical and analytical knowledge in relevant therapeutic areasDemonstrates excellent organizational and management skillsEffective communicator with strong verbal and written skillsSeen as a strong, influential leader and manager of employeesCreates strong morale and spirit on his/her teamAble to think creatively; develop and execute within a fast-paced environment10% domestic travelJoin Our Inclusive TeamADC Therapeutics is proud to be an Affirmative Action/EEO Employer
EOE Minorities/Females/ProtectedVeterans/Disabled
We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.Attention: Search firms/Third-party recruitment agenciesThe People team manages the recruiting for all positions at ADC Therapeutics
We will only accept résumés from a search agency/recruiter if we have a signed agreement in place and we have formally requested your help on a specific role
Forwarding unsolicited resumes on behalf of potential candidates and/or vendor engagement requests to ADC Therapeutics hiring managers is strictly prohibited
Unsolicited résumés sent to ADCT will be considered property of ADCT
We will not be responsible for any fees associated should we hire from unsolicited résumés
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