Associate Director, Clinical Drug Supply, Clinical Trial Commercial Product – Buyer Planner

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.

Purpose:

The Clinical Drug Supply (CDS) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the Clinical Design, Delivery & Analytics (CDDA) and Clinical Supply and Delivery (CSD) to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.

The role of the Clinical Trial Commercial Product, Buyer Planner (CPBP) is to ensure a robust strategy and integrated plan for supplying Commercial Products that supports Lilly Clinical Trials, externally sponsored research, Expanded Access Programs, and decentralized and clinical material trial regulations. The CPBP will use their global expertise for commercial products (procurement, wholesalers, supply chain, etc.) in developing strategies for supplying commercial products to support clinical trials. The CPBP is accountable for development of the Materials Master Requirements Plan, purchasing decisions, and management of Product Delivery (PD) material flow to meet required timelines.  Moreover, the CPBP will use their supply chain expertise to influence demand forecasts and leverage innovate sourcing strategies.

This role is critical in delivering the Lilly portfolio and key development milestones.  The CPBP will anticipate and resolve technical issues with the supply chain and drive for solutions that meet the needs of the business. The CPBP will collaborate with Supply Planning to ensure the commercial product strategy meets the demands of the molecule/study plan as well as partners with the Commercial Product Material Coordinator to ensure execution of the strategy.

Key Responsibilities

• Participate in demand planning and sourcing strategy decisions considering regulatory requirements at a study and asset level through partnership with Supply Planning, Quality and Clinical.

• Have supply chain planning responsibility for Commercial Products, Lilly and Non-Lilly, to meet the demand plan supporting Lilly’s clinical trials and externally sponsored research.

• Work closely with Clinical Trial Supply Managers to understand trial operating model and any constraints/issues with the demand forecast that have implications for the supply plan.

• Initiate, establish, and maintain effective relationships with Lilly commercial and distribution sites, functional areas, and external partners

• Manages business planning, forecast development and tracking spend variances for supported Business Units. This includes supplying the annual and quarterly forecast updates.

• Be knowledgeable on how to apply GMPs/GCPs in a clinical trial environment. Review and follow procedures applicable to the clinical trial business to maintain compliance.

• Determine and execute planning heuristics in SAP/APO through Clinical Demand & Operations Planning process, review alerts and plan adjustments

• Optimize plan across the supply chain to ensure demand and minimum dating requirements for finished goods and locally sourced orders can be met or exceeded

• Effectively lead and communicate with the cross-functional Supply Planning and CT Material Operations team to delivery plan, foster an environment of integrated teamwork and collaboration, and influence without authority

• Develop and oversee execution of contingency plans across functions when supply issues arise

• Communication of team performance and wholesaler performance metrics relative to goals. Leverages relationships with key internal Product Delivery (PD partners and other business partners to influence a robust material supply chain (e.g., Quality, Manufacturing, Packaging, and Supply Planning)

• Leverage established relationships with external suppliers (e.g., wholesalers, pharma companies) to influence delivery lead times, cost savings and improving performance metrics)

• Leads, coaches and mentors Commercial Product Material Coordinators with potential to have reporting accountabilities

• Drives process improvement, searching for opportunities to improve productivity, efficiency, compliance, and data accuracy

• Develop supply strategies that meet the needs of the business by using data, expertise, and key relationships

• Maintain expertise on clinical trial materials MRP processes, joint Lilly/ Collaboration Partner processes as well, as how those processes connect to PD and Lilly business processes.

• Partnering with Product Delivery, Clinical, Regulatory, Procurement, Finance, BU’s and other MDU functions to clearly understand commercial product and broad PR&D needs and develop a strategy to meet those needs.

• Drive actions and solutions from observations, deviations, and change controls, as necessary.

• Ensure the execution of the integrated strategy for pharmaceutical drug material (Market Pharmaceutical Product or Non- Market Pharmaceutical Product) that is introduced into the Lilly Clinical Supply chain driven from external collaboration and business development activities.

Minimum Qualification Requirements:

• Bachelor’s degree (Supply Chain, Logistics, PharmD, Business) or equivalent work experience.

• 5 years pharma or clinical trial experience

• Experience in managing inventory/supplies, including commercial product or investigational drug supply chains   

• Experience working with and managing third parties 

• Knowledge of clinical trial packaging 

• Working knowledge of GMP/GDP/GCP regulations.

• Ability to use and apply multiple computer applications, including proficiency in computer technology used in office and supply chain environments (e.g., SAP)  

• Minimum 1-year previous GMP supply chain experience

• Application knowledge of business planning and control systems to collect, consolidate, analyze, summarize, and report on large volumes of supply chain data

• Ability to build productive relationships and effectively communicate with other Product Delivery team members (Packaging, Quality, Supply Planning. Labelling etc.) 

Other Information/Additional Preferences:

• Master’s degree preferred

• Project management experience preferred

• Knowledge of Import/Export compliance as it related to clinical trials and shipping medicinal products 

• Prior experience in ERP system 

• Prior experience with SAP is preferred 

• Prior experience with GMP supply chains (wholesaler, manufacturer, CMO) 

• Prior experience with Procurement 

• APICS certification

• Language Requirements: Must be Fluent in English (both written and spoken).   

• Additional Information/Requirements:  

  • Work outside of core hours may be required to support the portfolio across the globe.

  • Roles posted in Cork may be requested to work flexible hours.

  • May require travel domestically and international (less than 5%) 

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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