Lilly Associate Director - Clinical Trial Supply Management in Cork, Ireland
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 35,000 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Clinical Supply Planning and Systems (CSPS) function is accountable for partnering with drug development teams, clinical, PRD, and the broader Product Delivery Organization to enable innovative supply chain solutions and speed the delivery of clinical trial materials for patients.
This is accomplished by planning and scheduling via a Material Requirements Planning (MRP) system (SAP)and communications with key business partners. The Clinical Trial Supply Management Associate Director is responsible for collaborating with the Product Delivery Supply Sr. Director and the broader Product Delivery organization to influence clinical trial design and supply chain strategy for all molecules and trials in development, including the most complex.
The Clinical Trial Supply Management Associate Director is responsible for developing demand forecasts and inventory management strategies at hubs, depots, and sites then executing the strategy in partnership with cross-functional operational teams.
The Clinical Trial Supply Management Associate Director is the primary contact to the global clinical team for the trials they support. The Clinical Trial Supply Management Associate Director will drive robust, strategic discussions with their clinical and functional counterparts to develop different supply scenarios that meet trial intent while looking for efficiencies and speed. The clinical demand forecast and inventory management strategies developed by the Clinical Trial Supply Management Associate Director drives planning and execution activities across Product Delivery, other functions, and internal and external manufacturing, packaging, and distribution plants around the globe.
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.
•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
Language Requirements: Must speak fluent English
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.
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Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!