Description

Global Safety Physician

New Providence, NJ/Hybrid/Remote

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 a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and is awaiting approval in the European Union. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We are a team of over 300 patient-focused, purpose-driven employees who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!

To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on LinkedIn.

Position Overview

The Global Safety Physician will serve as the safety expert for assigned products. The Global Safety Physician is responsible for signal detection and evaluation, aggregate safety reviews, periodic aggregate safety report preparation, and the oversight of vendors for Individual Case Safety Reports (ICSRs). 

The Global Safety Physician will support the continued development of the Drug Safety and Pharmacovigilance (DSPV) organization. 

This position can be remote based in the US. There is a preference to be based on the East Coast with the ability to travel to the New Providence, NJ office as needed for business meetings. This role reports into the VP, Drug Safety. 

Job responsibilities

• Responsible for all safety data throughout the life-cycle for assigned product(s)
• Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis.
• Will develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Responsible for content in the aggregate reports (such as DSUR, PADER, PBRER) and Risk Management documents (RMPs) for assigned products.
• Perform medical oversight to the vendor on ICSRs, literature review, signal evaluation and aggregate report to ensure accuracy and completeness of the safety content.
• Review and contribute to safety sections within clinical documents such as Investigator’s Brochure, Study Protocol, and Informed Consent Forms. 
• Support cross-functional safety management team meetings and collaborate with team members to ensure patient safety for assigned products. 
• Support and collaborate with cross-functional teams on safety related activities, preparing and presenting safety data at meetings, providing responses to Health Authority requests, or business development queries.
• Provide support for the Safety Scientist on assigned work, such as vendor oversight. 
• Collaborate effectively with key stakeholders, including business partners and vendors, and ensure they are informed of evolving safety issues and strategies.
• Support and contribute to the development of Pharmacovigilance Agreements as needed. 

Requirements

Requirements

• MD, required. 
• 5 years of relevant experience in drug safety, depending on qualification, within the biotechnology or pharmaceutical industry is required. Oncology experience is preferred. 
• In-depth knowledge of pharmacovigilance regulatory requirements, ICH guidance, and other relevant regulatory guidance.
• Knowledge of drug development process, safety monitoring and risk/benefit analysis in clinical trials. 
• In-depth knowledgeable of individual case medical review, signal detection and evaluation, aggregate data review and report, as well as safety labeling. 
• Experience with the writing/reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels.
• Ability to work independently, and collaborate effectively with key stakeholders, including business partners and vendors. Good team player with the ability to be flexible. 
• Proficient with Microsoft Office. 
• Strategic thinking, strong writing and analytic skills, excellent verbal, written communication skills.