Associate Director – Clinical Drug Supply

Associate Director – Clinical Drug SupplyAt 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. We are a global healthcare leader headquartered in Indianapolis, Indiana. 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. 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Organisation Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism
In addition to Lilly-sponsored research, Lilly provides support for Externally Sponsored Research (ESR) and Access programs with provision of Lilly drug products and/or financial support.
* Investigator Initiated Research (IIR) is initiated, designed, and sponsored by external researchers. Lilly considers such requests for support of Investigator Initiated Research (IIR) projects based on scientific merit and strategic fit with Lilly's areas of research interest.
* Expanded access is the provision of an investigational medicinal product (IMP) for treatment of patients with a serious or life-threatening condition who are unable or do not qualify to participate in a clinical trial and for whom no satisfactory alternative therapy is available. Expanded access is not conducted for the purpose of answering research questions. Expanded access is known by other terms in different countries, such as compassionate use, emergency use, authorization for temporary use, individual patient investigational new drug (IND), named patient use (NPU), and named patient access program.
* Externally Sponsored Collaborative Research (ESCR) may be initiated by the Sponsor or may be a collaborative effort to explore a research objective.
The role of the Associate Director, Externally Sponsored Research and Access Programs is to ensure a robust strategy and integrated plan for supplying Lilly drug products (investigational and commercial) to support Investigator Initiated Research, Externally Sponsored Collaborative Research, and Expanded Access Programs (IIR/ESCR/EAP). This is accomplished by partnering with the Business Units and across functional support (Quality, medical, medical affairs, legal, safety, CT supply planning, commercial manufacturing, finance, regulatory etc.) to develop strategies for drug supplies and execute the operational activities required for contracting, planning drug supplies, and managing project timelines in support of external researchers and patients worldwide.
The Associate Director will drive robust, strategic discussions with their clinical and functional counterparts to develop drug supply chain strategies that meet GMP/GCP/GDP requirements, timelines commitments to external researchers and health care providers, while looking for efficiencies and speed. The clinical demand forecast, and inventory management strategies developed by the Associate Director drives planning and execution activities across various functions, including internal and external manufacturing, packaging, and distribution plants around the globe.
Responsibilities
* Have supply chain planning responsibility for Lilly drug products to meet the demand plan supporting externally sponsored research.
* Collaborate with Product Delivery, Clinical, Regulatory, Procurement, Finance, BU's and other MDU functions to provide commercial product and broad PR&D needs and develop a strategy to meet those Requirements.
* Provide visibility to proactive demand planning that can rapidly accommodate changes in the quantity of drug product needed in light of fluctuating patient enrollment or unexpected changes to a trial.
* Work closely with Clinical and Business Units to understand trial operating model and any constraints/issues with the demand forecast that have implications for the supply plan.
* Fostering an environment of integrated teamwork and partnership via shared learning, accountability, influencing others without authority.
* Appropriately escalate from issue identification through resolution within Product Delivery and to the clinical function as it relates to CT supply.
* Initiate, establish, and maintain effective relationships with Lilly commercial and distribution sites, functional areas, and external partners. Leverage these established relationships to influence a robust material supply chain (e.g., Quality, Manufacturing, Packaging, and Supply Planning).
* Maintain GMP/GCP/GDP compliance by following procedures applicable to drug supply chains in support of investigational research and access programs.
* Manages business planning, forecast development and tracking spend variances for supported Business Units. This includes supplying the annual and quarterly forecast updates.
* Communication and roll-up of team performance metrics relative to goals.
* Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicate appropriately.
* Drives improvement, searching for opportunities to improve productivity, efficiency, compliance, and data accuracy while minimizing costs.
* Drive actions and solutions from observations, deviations, and change controls, as necessary.
Educational Requirements
* Bachelor's degree or relevant work experience preferably in a drug supply chain, health care or science related field.
Additional Preferences
* At least 5 years of drug supply chain or clinical trial research experience
* Working knowledge of GCP regulations and/or GMP/GDP requirements.
* Experience in managing inventory/supplies, including commercial and/or investigational drug supply chains.
* Experience in SAP planning or other supply chain applications
* Knowledge of Import/Export compliance as it related to clinical trials and shipping medicinal products.
* 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.
* Strong partnership and communication skills – internal and external partners
* Exceptional project management capabilities
* Previous cross-functional experiences
* APICS certification or other supply chain certification
* Experience working with third parties.
* Project Management experience.
* Ability to use and apply multiple computer applications, including proficiency in computer technology used in office and supply chain environments (e.g., SAP, EXCEL. PowerBI)
* High degree of accuracy with work and attention to details
* Ability to proactively identify problems and work toward a solution.
* Prior experience with GMP supply chains (wholesaler, manufacturer, CMO)
Additional Information/Requirements
* Language Requirements: Must be Fluent in English (both written and spoken).
* Work outside of core hours may be required to support the portfolio across the globe.
* May require travel domestically and international (less than 5%)
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ****** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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