Manager, Clinical Supply Chain

Key Responsibilities

Clinical Supply Planning & Execution Contribute to the development and execution of clinical supply strategies for early- to mid-phase clinical trials (Phase 1-3 as applicable). Manage clinical supply plans, demand forecasts, and inventory strategies - including tracking through Interactive Response Technology (IRT) systems - in alignment with protocol requirements and enrollment projections.

Support packaging, labeling, distribution, and resupply activities for investigational products and comparators. Ensure on-time delivery of clinical supplies to depots and clinical sites globally. Vendor & CDMO Management Partner with Quality, Clinical, CMC, and external CDMOs to develop, review, and approve clinical labels, and support CDMO packaging/labeling schedules to ensure supply availability.

Interact regularly with third-party providers to manage the logistics and licenses required to ship materials from manufacturing to bulk storage facilities, courier depots, and investigator sites. Collaborate with CMC and QA to facilitate the document transfer required for IP/QP release by CDMOs.

• Quality & Compliance Support Monitor shelf-life and expiry dating, and coordinate retest/extension activities with the analytical team to ensure continuous supply.
• Manage the investigation, reporting, and communication of outcomes from temperature excursions and product complaints.
• Support product recovery activities pending investigation of IP from investigator sites, as needed.

• Cross-Functional Collaboration & Representation Communicate effectively across functional areas, applying a solid working knowledge of clinical supply chain processes.
• Author Pharmacy Manuals for clinical studies, as needed.
• Represent Supply Chain in Clinical and CMC Sub-Team meetings.

Basic Qualifications

• Bachelor's degree in engineering or science required.
• 3-5 years of biotech/pharma industry experience in clinical supply chain, including international experience, required.
• Qualified applicants must be authorized to work in the United States on a full-time basis.

Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Working knowledge of clinical supply chain processes and GMP/GDP requirements. Experience coordinating cross-functional project teams and external vendors.

• Strong organizational, analytical, decision-making, and interpersonal skills, with excellent attention to detail.
• Ability to work independently in a fast-paced, dynamic environment.
• Demonstrated ability to coordinate CDMO activities supporting clinical development of pharmaceutical products.
• Ability to thrive in a small-company culture and contribute to creating and implementing processes.

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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $105,000 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly