Sr Medical Director

Date Posted: 10/16/2025

Senior Medical Director, Global Pharmacovigilance
Remote, NJ based company
Full time or Contract

Summary:
Expanding Biotech is looking for a Senior Medical Director to be the safety strategy leader in safety related and benefit risk decision making activities for assigned products. Must 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.

This position 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. This is also pivotal to the overall success of the products they are assigned to. They are empowered to work independently under the oversight of VP, Global PV.

In this role you will be 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 the company external stakeholders in the medical community, as well as with global regulatory authorities. Occasional travel required to the NJ office for business meetings. This position reports to the VP, Global Pharmacovigilance.

Description:
Responsible for establishing and maintaining the company position on the safety profile and to shape the risk management strategy and proactive patient risk communication for their assigned products. Develop and maintain an expert understanding of the safety profile of the assigned products as well as relevant strategic context (e.g., safety profile of existing standard of care, treatment landscape). Will recommend appropriate safety monitoring measures for safety issues, signal detection and evaluation, aggregate safety reviews, preparation of periodic aggregate safety report and the medical review oversight of vendors for Individual Case Safety Reports (ICSRs). 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. They contribute and provide expert content reviews for safety aspects of their product(s) for protocols, IBs, ICFs safety label updates, Safety management plan(s), Risk Management plan across the life cycle of the products. Lead cross-functional safety management team (SMT) 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.

Required:
Must have an MD. 13 years+ of relevant experience in drug safety, depending on qualification, within the biotechnology or pharmaceutical industry in the areas of Oncology is a must. Strong 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. Strong experience with 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.

Please contact Darren Gutowski at dgutowski@clarkdavis.com