Senior Manager Clinical Drug Supply & Logistics

Build our future together: The Senior Manager, Clinical Drug Supply & Logistics is responsible for providing oversight of individual or multiple clinical programs, forecasting Investigational Product (IP) supply requirements for multiple clinical trials, and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron SOPs / WPDs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability). When & where: Location: Armonk, NY / Warren, NJ / Cambridge, MA Work model/flexibility: in office 3-4 days per week Discover your role: Supply Planning Serves as lead drug supply manager of a program and/or individual studies for the functional area in supply planning, including demand forecasting according to IOPS requirements. Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan. Works with clinical drug supply management to determine resourcing needs. Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals. Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines. Inventory tracking Manages and oversees investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections. Shipments Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process. IVRS Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS. Works with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors. Leads effort for clinical supply management functionality. Monitors and manages clinical supply activities through IRT from study start-up through study closure. Returns & Destruction Develops strategy and oversees drug return and destruction activities. Expiry Management Develops resupply strategies based on stability and shelf-life of clinical supplies. Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry. Ancillary & Comparator Supplies #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc