Responsible for the project management of key Clinical Supply Chain activities at the protocol level for pre-clinical and Phase I - II clinical trials
Includes forecasting, planning, scheduling, coordination, and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
Develops protocol specific labeling compliant with applicable global regulations.
Identifies, develops, communicates, and tracks project timelines, activities, logistics, and milestones.
Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning.
Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies, and commodities, including overages.
Required Skills:
Education Requirement: Bachelor's Degree required preferably in physical science, math, engineering, or pharmacy.
Experience: 2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas:
Drug discovery (eg, Process Chemistry, Analytical Chemistry)
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