Forecasts, plans, schedules, coordinate and executes, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. Manages key Clinical Supply Chain projects and activities at the protocol level for Phase I-IV clinical trials of increasing complexity. Works under the supervision of Program Manager or Associate Director and directly with mentor.

Responsibilities

• 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 creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IRT vendors, quality assurance, clinical team partners, etc. to ensure timely availability of clinical supplies.
• 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.
• Participates in cross functional initiatives as drug subject matter expert.
• Leads in function improvement initiatives.