Associate / Sr. Associate - Clinical Drug Supply Management (Clinical Trial Supply Management)
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.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Main Purpose And Objectives Of Position
The Clinical Drug Supply organization team is responsible for providing Investigational Product (study drug) management services for global clinical trials in all development phases.
The Clinical Trial Supply Management Associate is responsible for collaborating with the Product Delivery Supply Senior Director, Clinical Trial Supply Managers, Molecule Planners and the broader Product Delivery organization to support supply chain planning and execution for all molecules and trials in development.
Key Responsibilities
* Collaborate with Product Delivery Supply Senior Directors, Clinical Trial Supply Managers, and Molecule Planners to provide expertise in supply chain methodologies.
* Be an active and engaged member of the global trial development team providing expertise 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.
* Determine appropriate operating model for forecasting and calculate the forecast with appropriate business-approved tools 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.
* 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.
* Create and deliver appropriate training and pharmacy manual creation as it related to CT material and supply.
* Maintain GMP/GCP compliance by following procedures applicable to CT execution.
* Communicate with affiliates, global team members, and external partners on timing for CT Material shipments and material availability.
* Problem solve CT Material issues in partnership with Supply Senior Director, Clinical Trial Managers, and Molecule Planners.
* 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 and execution.
* Understand how supply strategy and demand forecasts impact Product Delivery and Business Unit/Research budgets and proactively manage communication around budget and changes that impact the budget.
* 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.
* Support innovation and process optimization to speed drug development by influencing scenarios around supply strategies.
* 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.
Experience Requirements
* Strong project management abilities (timeline, scope, budget, risk management).
* Demonstrated problem-solving skills for complex issues.
* Strong organizational skills.
* Strong collaboration skills.
* Effective communicator.
* Ability to make decisions in the absence of an obvious answer/approach.
* Strong computer skill (i.e. Word, Excel, PowerPoint, Microsoft Project, other).
Additional Preferences
* Knowledge of CT material requirements including GCP and GMP requirements.
* Experience in supply chain and/or inventory management systems planning.
* Experience in clinical development.
* Project Management Certification or relevant Project Management experience.
* Licenses or Certifications: such as APICS, Supply Chain Certificate (via MBA or specific university program).
Language Requirements: Must speak and write fluent English.
Additional Information/Requirements
* Domestic and international travel may be required (10%).
* Work outside of core hours may be required to support the portfolio across the globe.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
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.
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