Lead Clinical Supply Chain operations for high complexity study and program, including strategy, budget and timeline development and adherence
Serve as the primary Clinical Supply Chain representative for high complexity programs cross-functional governance forums
Drive cross functional collaboration with internal and external stakeholders to align supply strategy with development, regulatory, and operational needs
Influence program-level decisions to optimize timelines, patient access, and budget compliance
Provide guidance and mentorship to team members, sharing best practices and tools to support excellent performance
End-to-end global clinical supply operations management including timelines, manufacturing, pack and label, logistics, inventory, reconciliation, and IRT
Translate clinical protocols into integrated demand forecasts and risk-adjusted supply plans across regions
Support long-range planning, scenario modeling, and financial forecasting
Provide input to Interactive Response Technology (IRT) system design and testing
Partner with Global External Operations to strategize on manufacturing operations, storage and distribution
Monitor and track manufacturing timelines and ensure alignment with clinical supply needs
Responsible for inventory management at patient level to ensure zero out of stock situations
Ensure compliance with global GxP, ICH, and regional regulatory requirements in clinical supply operations
Support regulatory filings and inspections as a subject matter expert; lead TMF preparation for investigational product supply
Drive SOP development, process improvements, audit readiness, and lead digital transformation initiatives
Requirements
Bachelor’s degree in a science-related field; advanced degree preferred
10+ years of experience in clinical supply chain, planning, or operations within the biotech/pharma industry
Proven ability to lead cross-functional teams, influence stakeholders, and manage complex supply planning scenarios
Experience with digital planning tools (e.g., SAP, Tableau)
Experience using the Smart Supplies Forecasting tool is preferred
Strong understanding of GxP, ICH, and regulatory requirements governing clinical supply activities
Strong understanding of technical drug development is advantageous