Associate Director Job In Cork

Job Description

We are seeking a highly skilled Clinical Trial Supply Management Associate Director to join our team at Lilly, a global healthcare leader. This individual will be responsible for collaborating with cross-functional teams to develop and execute clinical trial supply strategies, ensuring timely and accurate delivery of clinical trial materials to patients worldwide. **Job Summary** The Clinical Trial Supply Management Associate Director will lead the development and implementation of clinical trial supply strategies, working closely with global clinical teams, product delivery, and other functions to ensure seamless execution of clinical trials. This role requires a strong understanding of supply chain methodologies, clinical trial design, and inventory management. **Key Responsibilities** • Collaborate with Product Delivery Supply Sr. Director and Molecule Planners to provide expertise in supply chain methodologies and drive process improvements for productivity and efficiency gains. • Influence trial designs and protocol language around all aspects of clinical supply, ensuring adequate and timely supply of Clinical Trial (CT) Material to support CT execution. • Translate protocol or planned protocol requirements into demand forecast, influencing supply strategy and determining appropriate operating model for forecasting. • Manage accurate CT Material demand forecast via MRP System (SAP) per business processes, regularly re-evaluating the demand forecast to align with CD&OP. • Utilize forecasting techniques and site inventory management tools to ensure CT Material supply at sites, hubs, and depots throughout the life of a trial. • Coordinate initial shipment strategy and execution to clinical sites, leveraging systems and tools to maintain proper inventory levels and timely, reliable shipment forecast. • Perform trial-level risk assessments on CT Material quantities and expiry dates throughout the life of trial, calculating and re-assessing quantities for trial-level import permits as necessary. • Ensure proper destruction of material, as appropriate, and maintain GMP/GCP compliance by following procedures applicable to clinical trial execution. • Communicate with affiliates, global team members, and external partners on timing for CT Material shipments and material availability, problem-solving CT Material issues including temperature excursions, material needs, shipment receipt, and other issues. • Create, review, and/or approve appropriate documents outlined in business processes, appropriately escalating from issue identification through resolution within Product Delivery and to the clinical function as it relates to CT supply. • Understand how supply strategy and demand forecast affects Product Delivery and Business Unit/Research budgets, communicating cost considerations for various trial supply options as an input into decision making, and proactively managing communication around changes that impact the Product Delivery budget for a trial. • Provide information, as requested, for budget development and/or changes to an existing budget as they relate to the demand forecast or supply strategy. • Reach across boundaries and integrate information from external and internal collaborators to bring together diverse perspectives for supply plans, supporting innovation and process optimization to speed drug development by influencing scenarios around supply strategies and business process improvement. **Requirements** • Bachelor's degree or relevant work experience preferably in health care or sciences-related field. • At least 8 years of supply chain or clinical trial research experience. • Exceptional critical thinking, strategy development, and decision-making skills. • Ability to develop strategies and make decisions in the absence of an obvious answer/approach. • Demonstrated problem-solving skills. • Exceptional organization and time management skills. • Strong partnership and communication skills – internal and external partners. • Exceptional project management capabilities. • Knowledge of investigational product requirements – GCP and GMP. • Experience in SAP planning. • APICS, Supply Chain Certificate (via MBA or specific university program). • Project Management Certification. • Formal Project Management Experience. • Inventory and supply management expertise. • Clinical research/study expertise, including: • How study or supply chain variability impact planning. • How study supplies are determined and managed. • How study blinding is maintained.