Sr. Director, Global Clinical Supply Chain, GCO ( Global Clinical Operations)

Role Summary

Sr. Director, Global Clinical Supply Chain, GCO (Global Clinical Operations). Based in Parsippany, NJ or West Chester, PA in a hybrid environment, 2-3 days onsite. Lead end-to-end clinical supply operations across Phases 1–4, optimizing, executing, and transforming the global clinical supply chain—including forecasting, planning, packaging and labeling operations, IRT/RTSM strategy, distribution, cold-chain management, depot oversight, vendor/CMO management, and returns/destruction. Oversee sourcing, secondary packaging operations, and integration with Finance/ERP systems for procurement and financial governance.

Responsibilities

• Lead the Global Clinical Supply Chain function with full accountability for strategy, operations, team development, and continuous improvement.
• Build, mentor, and motivate a high performing team, fostering a culture of operational excellence, collaboration, and innovation.
• Develop and implement talent management strategies, including recruitment, training, and career development.
• Provide leadership across sourcing and packaging teams and oversee financial planning and accruals.
• Shape the future state of global clinical supply chain operations, driving alignment across regions and functions.
• Provide strategic leadership in a collaborative partnership model—driving alignment, governance, and seamless communication across other pharmaceutical organizations as needed to ensure integrated clinical supply strategies and execution.
• Oversee forecasting, demand planning, supply strategy, packaging, labeling, and global distribution for all clinical programs (Phases 1–4).
• Manage 80% in-house packaging and labeling operations while overseeing external CMO/CRO partners.
• Ensure global depot management, import/export compliance, cold-chain integrity, and controlled substances governance.
• Oversee IRT/RTSM strategy, configuration standards, and integration with supply systems for real-time visibility.
• Support ANDA submissions and portfolio launches through compliant supply chain practices.
• Lead vendor selection, guide contract negotiations, and performance management across packaging/labeling, distribution, depots, and IRT.
• Ensure compliant and efficient oversight of CRO and CMO supply-chain activities for largely outsourced studies.
• Manage procurement and vendor contracts for sourcing and packaging operations.
• Ensure adherence to GxP, GDP, GCP, and international regulatory requirements.
• Proactively identify and mitigate supply chain risks; ensure robust scenario planning and contingencies.
• Lead SOP development and governance for consistency, quality, and scalability.
• Champion digital and data-driven initiatives (shipment tracking, forecasting tools, supply visibility platforms, automation, analytics).
• Drive process simplification and implement technology enhancements to optimize speed, accuracy, and efficiency.
• Drive standardization and end-to-end process mapping to support scalability and operational maturity.
• Implement KPI frameworks and AOP/budget ownership for supply assurance and performance monitoring.
• Ensure operational alignment with corporate priorities, lead AOP/LBE/RF budgeting processes, and implement procurement strategies for cost optimization.

Qualifications

• Required: Bachelor's Degree.
• Required: Minimum of 12 years in clinical supply chain with global experience (US, EU, international).
• Required: Proven leadership of end-to-end global clinical supply operations for Phases 1–4.
• Required: Demonstrated success developing and leading teams during phases of rapid growth or transformation.
• Required: Experience managing internal packaging/labeling operations and outsourced vendors/CMOs.
• Required: Strong understanding of IRT/RTSM systems, forecasting tools, global depot management, and cold chain operations.
• Preferred: Bonus: experience driving digital supply chain innovations and process simplification.