Role Summary
Sr. Director, Global Clinical Supply Chain, GCO (Global Clinical Operations) lead end-to-end clinical supply operations across Phases 1–4, overseeing forecasting, planning, packaging and labeling, IRT/RTSM strategy, distribution, cold-chain management, depot oversight, vendor/CMO management, and returns/destruction. Also responsible for sourcing, secondary packaging operations, and integration with Finance/ERP systems for procurement and financial governance. Based in Parsippany, NJ or West Chester, PA in a hybrid environment (2-3 days onsite).
Responsibilities
- Lead the Global Clinical Supply Chain function with accountability for strategy, operations, team development, and continuous improvement.
- Build, mentor, and motivate a high-performing team, fostering 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 and align across regions and functions.
- Provide strategic leadership in a collaborative partnership model 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 and integration with supply systems for real-time visibility.
- Support ANDA submissions and portfolio launches through compliant supply chain practices.
- Lead vendor selection, contract negotiations, and performance management across packaging/labeling, distribution, depots, and IRT.
- Ensure compliant oversight of CRO and CMO supply-chain activities for outsourced studies.
- Manage procurement and vendor contracts for sourcing and packaging operations.
- Ensure adherence to GxP, GDP, GCP, and international regulatory requirements; identify and mitigate supply chain risks; lead SOP development and governance.
- Champion digital and data-driven initiatives (shipment tracking, forecasting tools, supply visibility platforms, automation, analytics).
- Drive process simplification and technology enhancements to optimize speed, accuracy, and efficiency; standardize end-to-end processes for scalability.
- Implement KPI frameworks and ownership of budgeting processes; align operations with corporate priorities and implement procurement strategies for cost optimization.
Qualifications
- Bachelors Degree
- Minimum of 12 years in clinical supply chain with global experience (US, EU, international)
- Proven leadership of end-to-end global clinical supply operations for Phases 1–4
- Experience building and leading teams during rapid growth or transformation
- Experience managing internal packaging/labeling operations and outsourced vendors/CMOs
- Strong understanding of IRT/RTSM systems, forecasting tools, global depot management, and cold chain operations
- Bonus: experience driving digital supply chain innovations and process simplification
Skills
- Strategic leadership and organizational development
- Vendor and CMO/CRO oversight and contract management
- Regulatory compliance across GxP, GDP, GCP
- Digital transformation and data-driven decision making
- Forecasting, demand planning, and inventory management
- Change management and cross-functional collaboration
Education
- Bachelors Degree (as stated in Qualifications)