Senior Medical Director-Global Drug Safety

ADC Therapeutics SA - New Providence, NJ

Full-time - Senior

Hybrid - New Providence, NJ

251-500 employees

Chemical Manufacturing

About the position

The Senior Medical Director will serve as the product safety physician and expert for assigned products at ADC Therapeutics (ADCT) in the Global Drug Safety function. The Senior Medical Director is responsible for signal detection and evaluation, aggregate safety reviews, periodic aggregate safety report preparation, and the medical review oversight of vendors for Individual Case Safety Reports (ICSRs). 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 working within product teams. 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. 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 to the VP, Global Drug Safety.

Responsibilities

• Responsible for all safety data review, understanding, and messaging throughout the life-cycle for assigned product(s).
• Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis in collaboration with the PV Scientist and/or Clinical Physician/Scientist.
• 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 of vendors 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.
• Lead 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.
• Provide strategy and input into development of product risk strategy and documents as needed including RMP and REMS.

Requirements

• MD, required.
• 8 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.
• Demonstrated ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture.
• Demonstrated sense of urgency and accountability for both individual and team-owned work products.
• Proficient with Microsoft Office.
• Strategic thinking, strong writing and analytic skills, excellent verbal, written communication skills.