Associate Director Job In Cork

Job Description

Clinical Trial Supply Management Associate Director

Summary: Lead the development of clinical trial supply strategies and manage demand forecasts to ensure timely and adequate supply of clinical trial materials.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.

Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

• 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.
• Ensure adequate and timely supply of Clinical Trial (CT) Material to support CT execution.
• Translate protocol or planned protocol requirements into demand forecast and influence supply strategy.
• Manage accurate CT Material demand forecast via MRP System (SAP) per business processes.
• Regularly re-evaluate the demand forecast to align with CD&OP.
• Create and deliver appropriate training and pharmacy manual creation as it relates to CT material and supply.
• 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.
• Perform trial-level risk assessments on CT Material quantities and expiry dates throughout the life of the trial.
• Calculate and reassess quantities for trial-level import permits, as necessary.
• Ensure proper destruction of material, as appropriate.
• 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 solve 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 escalate 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, communicate cost considerations for various trial supply options as an input into decision making, and proactively manage 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.
• Create, review, and/or approve appropriate documents outlined in business processes.
• Support innovation and process optimization to speed drug development by influencing scenarios around supply strategies and business process improvement.

• 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 impacts planning.