Description:
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.
In addition to Lilly-sponsored research, Lilly provides support for Externally Sponsored Research (ESR) and Access programs with provision of study drug 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 Clinical Central Services function partners 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 executes the operational activities required for contracting, planning drug supplies, and managing shipments for researchers and patients worldwide.
The Externally Sponsored Research and Access Programs Drug Supply Coordinator is responsible for the global supply chain coordination of drug supply (clinical trial supply in addition to Lilly commercial products) in support of Investigator Initiated Research (IIR), Expanded Access Programs (EAP), and other ESCR programs. Partnering cross-functionally is key to ensuring the appropriate drug supply products are procured and delivered to meet patient needs around the globe.
Key Responsibilities
- Participate in demand planning and sourcing strategy conversations for externally sponsored research and access programs as needed.
- Provide portfolio visibility and clear traceability at the appropriate level of all commercial products.
- Coordinate externally sponsored research and expanded access upfront processes from contracting through initial shipments.
- Own order fulfilment activities from order placement through material delivery including dating needs, delivery schedule and priorities.
- Establish effective relationships with external industry collaboration partners, clinical trial packaging collaboration partners and distribution sites, Lilly commercial supply chain, and functional areas across the clinical trial packaging organization.
- Coordinate activities and communicate timing on outgoing shipment schedules.
- Troubleshoot and resolve purchasing, material fulfilment and operational level issues as they arise.
- Identify and participate in continuous process improvements to improve productivity, compliance, and data accuracy.
- Identify supply concerns, when appropriate, and help drive action plans.
- Manage material inventories or communicate current inventory status.
- Facilitate demand requirements review with cross functional team and facilitate alignment to a unified plan.
- Author observations, deviations, and change controls, as necessary.
- Serve as point operational contact for supply chain relationships, track key metrics and provide issue escalation, as necessary.
- Utilize QDocs, VaultClincal, TrackWise, CTWIN and other systems.
Minimum Qualification Requirements
- Bachelor’s degree preferred (Supply Chain, Logistics, PharmD, Business) or equivalent work experience.
- Experience in managing inventory/supplies and/or experience managing commercial product or development supply chains
- Experience working with third parties
- Working knowledge of GMP/GDP/GCP regulations.
- Minimum 1-year previous GMP supply chain experience