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. We expect that activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron SOPs / WPDs. We forecast that the Sr. Manager will contribute to ongoing process improvement initiatives. We believe the 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).
A Typical Day Includes: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.This Job May be for You If:You are a strong collaborator and can effectively communicate globallyYou are able to work in ambiguous environmentsYou have a robust amount of knowledge in supply chain and able to forecast logistical mattersTo be considered, we are looking for you to have 8+ years of Life Science experience and 5 years of clinical supply management. Lastly, we expect you to be onsite a few days a week in one of our offices.
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