The Manager, Investigational Supply Operations is responsible for managing the forecasting, packaging and distribution of clinical trial material (CTM) to successfully support global clinical trials. Key responsibilities in this role include preparing clinical drug projections, monitoring clinical drug supply inventories, coordinating label development, procuring comparator drug, packaging investigational supplies, planning depot resupplies, managing depot to depot and depot to site shipments, and acting as the main point of contact to internal and external parties as it relates to clinical drug supplies.
The main responsibilities of this role include, but are not limited to:
- Function as Clinical Supply point person on assigned projects, including identifying, highlighting, and communicated associated risk.
- Develops and optimizes CTM forecasts based on clinical protocols and close interactions with Clinical Operations and Technical Operations to ensure appropriate supplies are delivered on time for each protocol and each country/region to meet key project milestones within budget
- Continually monitors changes to clinical study plans (i.e. shifting assumptions for enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans in order to keep CTM supply current
- Provides input to IXRS specification design. Reviews and critiques assigned IXRS threshold levels and optimizes if necessary to make efficient use of clinical supplies while avoiding stock outs at study sites
- Develops strategies for proactively monitoring depot inventory levels and initiating resupplies or transfers to avoid supply interruptions to study sites
- Secures appropriate sources for clinical co-therapy or comparator products if needed
- Schedules timely delivery of all necessary information and clinical supply materials, such as bulk drug, label and packaging design, randomization schemes, packaging and shipping configurations, labeling and distribution plans.
- Work with QA, other Technical Operations members, Clinical Operations and Regulatory CMC on ensuring that documentations governing clinical trials CMC (e.g. IMPD) are up to date
- Oversee logistics of shipments and temperature excursions. Provides expertise and assistance in international shipping requirements and interacts with regulatory to facilitate the compilation of required information
- Reduce costing through understanding of custom regulation at countries where depots and clinical sites are located
- Manage and track drug product shipments to clinical sites and follow up us needed to ensure disposition.
- Maintain inventory levels of packaging and distribution components.
- Identifies, contracts, and manages external resources and vendors to accomplish defined clinical supply plans as necessary for packaging, labeling and distribution
- Maintains standard operating procedures and policies related to global clinical labeling, packaging, shipping, destruction, and export of investigational drug product as required according to GXPs and global regulations
- Proposes packaging and labeling resupply schedules based on forecast, actual inventory and usage and production lead times
- Bachelor’s degree or higher preferably in a science discipline with at least 5 years in a position directly related to successfully managing clinical supplies. Excellent leadership, organizational, computer and communication skills and ability to multi-task while maintaining attention to detail
- Significant knowledge of packaging/labeling/distribution cGMP regulations, clinical study design execution, and packaging development procedures.
- Applicants must have strong technical and operational knowledge of the distribution practices in temperature-controlled distribution and exceptional project management abilities, particularly within complex clinical programs.
- Clinical study design execution and packaging development procedures.
- Ability to travel of up to 20%