Associate Director - Clinical Trial Supply Management
Eli Lilly
- Cork
- Permanent
- Full-time
- Collaborate with Product Delivery Supply Sr. Director and Molecule Planners to provide expertise in supply chain methodologies while continually looking for internal and external advancements to grow technical expertise and drive processes improvements for productivity and efficiency gains.
- Be an active and engaged member of the global trial development team influencing 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:
- Influence supply strategy
- Determine appropriate operating model for forecasting and calculate the forecast with appropriate business-approved tool and processes.
- 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 related to CT material and supply.
- Utilize forecasting techniques and site inventory management tools to ensure CT Material supply at sites, hubs, and depos throughout the life of a trialo Coordinate initial shipment strategy and execution to clinical sites .
- Leverage 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 life of trial
- Calculate and re-assesses quantities for trial-level import permits, as necessary
- Ensure proper destruction of material, as appropriate.
- Maintain GMP/GCP compliance by following follow procedures applicable to clinical trial execution
- Communicate with affiliates, global team members, and eternal 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 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.
- Fostering an environment of integrated teamwork and partnership via shared learning, accountability, influencing others without authority.
- Make quality culture the foundation of your work, to ensure our products are safe and effective to improve patients’ lives.
- 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
- Work outside of core hours may be required to support the portfolio across the globe
- Minimal travel may be required, both domestic and international.