Associate / Sr. Associate - 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. 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. 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.

At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. Our 41,000 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. Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Main Purpose and Objectives of Position:

The Clinical Drug Supply organization team 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 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. The Clinical Trial Supply Management Associate is responsible for developing demand forecasts and inventory management strategies at hubs, depots, and sites then executing the strategy in partnership with supply planning staff and cross-functional operational teams across trials or subsets of trials as assigned. The Clinical Trial Supply Management Associate will collaborate with their clinical and functional counterparts to develop different supply and execution scenarios that meet trial intent while looking for efficiencies and speed.

Key Responsibilities:

- Make quality culture the foundation of your work, to ensure our products are safe and effective to improve patients’ lives.
- Collaborate with Product Delivery Supply Senior Directors, Clinical Trial Supply Managers, 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 providing expertise around all aspects of clinical supply.
- Ensure adequate and timely supply of Clinical Trial (CT) Material to support CT execution.
- As assigned, 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.
- Ensure alignment on modelling with Product Delivery Supply Senior Director.
- Manage accurate CT Material demand forecast via MRP System (SAP) per business processes.
- Regularly re-evaluate the demand forecast to align with CD&OP.

- As assigned, 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.
- 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-assess quantities for trial-level import permits, as necessary.

- Create and deliver appropriate training and pharmacy manual creation as it relates 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 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 and execution in partnership with Product Delivery Supply Senior Directors.
- 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 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.
- 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.

Educational Requirements:

• Bachelor’s degree, preferably in health care or sciences related field or 3+ years work experience in supply chain management or clinical development.

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 skills (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.

Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

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