Senior Clinical Drug Supply Manager

The Senior Clinical Trial Drug Supply Manager is a critical position within the clinical development organization directly supporting the execution of clinical trials and regulatory submissions. This role will be responsible for multiple global studies and the independent oversight of drug supply forecasting, operational planning and execution, supply coordination, internal quality, packaging, distribution and expiry date management strategies. This position provide cross-functional leadership with significant regulatory and operational accountability with Clinical Operations and Clinical Development, Clinical Supply Chain, Manufacturing, Regulatory, Quality, and external vendors.

Essential Functions:

• Clinical Supply Planning & Execution: Develop and maintain demand forecasts based on study protocols, enrollment assumptions, and country/site activation plans; Support development and maintenance of study supply plans and timelines for all studies (e.g., Oncology, Parkinson's Disease studies); Lead in planning supply strategies for multiple global complex trials (e.g., dose escalation cohorts, randomized arms, combination therapies); Track randomization, study enrollment, drug supply management and adjust supply forecasts to ensure alignment with study needs, utilizing external Interactive Response Technology (IRT) system; Coordinate global supply activities including inventory and storage management, depot stocking, re-supply strategies, expiration management, IMP destruction, IMP shipping conditions across multiple clinical studies and regions to ensure uninterrupted drug availability at sites
• Investigational Product (IP) Management & Documentation: Coordinate packaging, labeling, kit design, and distribution of investigational product (IP), comparators, and ancillary supplies to clinical sites, depots; Monitor inventory levels with tracking systems (e.g., IRT/IVRS/IWRS), shelf-life, and expiry management for temperature-sensitive and high-value therapies; Support re-labeling, re-packaging, and returns/destruction activities as required; Ensure accurate documentation of supply activities in compliance with regulatory requirements; Support preparation of study-related documentation (e.g., packaging orders, shipping records, reconciliation reports)
• Study Team Partnership - Vendor & Stakeholder Management: Serve as a point of contact for external vendors including Clinical Research Organizations (CROs), packaging providers, depots and the Clinical Study Drug Coordinator on cross-functional study teams; Collaborate with Clinical Operations and site personnel to address supply-related inquiries and ensure site readiness; Support vendor oversight activities, including performance tracking and issue escalation; Communicate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Quality Assurance; Collaborate closely with Clinical Operations to align supply strategies with study design, enrollment, and timelines; Provide input into protocol design (e.g., dosing schedules, packaging configurations, blinding strategies) to ensure supply efficiency
• Logistics & Global Distribution: Track global shipments and resolve logistics issues such as delays, temperature excursions, or customs holds; Coordinate with depots, couriers, packaging vendors and customs agents to resolve shipping delays, temperature excursions, or import/export issues, to ensure timely delivery; Maintain accurate distribution records and documentation
• IRT/IWRS & Inventory Oversight: Support configuration and maintenance of Interactive Response Technology (IRT/IRT systems) for study supply management; Monitor system-generated inventory and trigger resupply actions; Support system setup, user acceptance testing (UAT), and go-live readiness; Reconcile inventory discrepancies and support accountability processes
• Compliance & Quality Assurance: Ensure all clinical supply activities are conducted in alignment with GCP, GMP, GDP, and company SOPs; Maintain accurate and audit-ready documentation including shipping records, temperature logs, and inventory reports; Support inspections and audits by regulatory authorities and internal quality groups; Support regulatory filings (e.g., IND/CTA submissions) with accurate drug supply documentation; Participate in deviation management, root cause analysis, and CAPA implementation
• Financial & Inventory Oversight: Manage clinical supply budgets, including packaging, distribution, and inventory costs; Optimize inventory levels to minimize waste while ensuring uninterrupted supply; Track and report key financial and operational metrics Process Improvement & Innovation: Drive improvements in clinical supply planning processes, systems, and data analysis; Enhance forecasting accuracy and supply chain visibility; Leadership & Team Development: Lead, and mentor a team of internal and/or external clinical drug supply professionals; Foster a culture of collaboration, accountability, and continuous improvement; Support organizational growth and capability building within Clinical Supply Chain