• Own end-to-end clinical supply chain strategy for active and upcoming trials
• Develop and maintain clinical drug supply forecasts and demand plans, translating protocol design, enrollment projections, and dosing regimens into packaging, labeling, and distribution plans.
• Select and manage clinical packaging, labeling, and distribution vendors, including oversight and performance management of CMOs/CPOs and specialty distribution/depot partners.
• Own Interactive Response Technology (IRT/IWRS) requirements, build, and testing in partnership with Clinical Operations, and serve as the clinical supply lead on IRT vendor management.
• Manage comparator and ancillary supply sourcing, including global sourcing strategies where applicable.
• Oversee cold chain and temperature-controlled logistics, expiry/re-test date management, and label reconciliation across depots and sites.
• Partner with CMC/Technical Operations to align clinical supply timelines with drug substance and drug product manufacturing schedules.
• Ensure compliance with GMP, GCP, and applicable import/export regulations across all clinical supply activities, including serialization and country-specific labeling requirements.
• Support regulatory submissions with clinical supply chain content (e.g., IMPD/IND sections, label text) in partnership with Regulatory Affairs and Quality.
• Manage clinical supply budget, purchase orders, and vendor invoicing in partnership with Finance.
• Build scalable clinical supply chain processes and systems as Frontier’s clinical portfolio and trial complexity grow.