Director

• Manage investigational products supporting clinical development pipeline and studies, ensuring on-time delivery of study drug to participants and overall clinical supply chain management (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM)
• Develop clinical forecast / demand plans based on trial requirements; identify supply chain risks and implement mitigation plans
• Work with cross-functional teams to define clinical supply plans and provide clinical supply status reports
• Review clinical protocols for study supply requirements and contribute to study drug packaging design
• In collaboration with quality, create label text in compliance with regulations and manage translations and country-specific requirements
• Manage vendors for labeling, packaging, and global distribution of investigational product and ancillary supplies
• Develop IRT (IXRS) supply and return strategy, lead IRT/IXRS setup, and participate in User Acceptance Testing
• Manage evaluation of temperature excursions and cold-chain logistics
• Develop requirements/specifications for clinical study drug and other drug supply, including packaged product, shipping and storage specifications
• Contribute to study-specific pharmacy manuals and supply-related training/instructional materials
• Coordinate with Supply Chain for use of commercial products in clinical environment
• Stay current on Korro SOPs related to CTM/IMP distribution and follow procedures for release of IMP to clinical sites
• Develop clinical supply budget and forecasting and track invoices to contracts
• Provide Regulatory Affairs with applicable information or sections for IND/IMPD/CTA/etc. submissions
• Report to VP Clinical Operations and interact with Technical Operations, Clinical Development, Quality, Regulatory, and external vendors

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