Role Summary
Lead, Clinical Supply Chain Planning at Lilly. Responsible for planning and scheduling clinical batches, coordinating with manufacturers/CMOs, and ensuring timely, compliant distribution of radiopharmaceuticals for clinical programs. Remote-based in North America, preferably EST.
Responsibilities
- Collaborate with clinical operations, CMOs and the manufacturing team to ensure uninterrupted supply and timely delivery of clinical products throughout the clinical trial life cycle
- Maintains and supports electronic files required for clinical supply (RAM licenses, site information database, shipping documentation, etc.)
- Ensures batches are scheduled to maximize units per batch
- Evaluates, maintains and tracks supply chain KPIs and contributes to continuous improvement for supply chain processes
- Develops and maintains good relationships with partners, CROs, CMOs, vendors and suppliers
- Communicates and escalates supply chain risks to management with a sense of urgency and provides mitigation strategies
- Provides verbal and written reports to manager in a clear and concise manner
- Maintains accurate and complete supply chain tracking logs (Excel format)
- Adheres to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements
- Contributes to the development and approval of supply chain procedures for clinical programs
- Embodies and promotes a quality culture and “right-first time” approach as part of all activities
- Works well in a fast-paced team environment
- Performs other duties as assigned
Qualifications
- Bachelor’s degree in Business, Supply Chain/Procurement, Engineering, Science or related field of study; or equivalent experience
- 5+ years of supply chain and/or manufacturing scheduling experience
- Experience in MS Excel with ability to develop and manage complex workbooks
- On-call availability outside of core business hours to support weekend deliveries
Additional Preferences
- Early start time (5am ET) may be required to support EU clinical sites
- Experience with IWRS/IP ordering platforms
- Experience with MRP/ERP
- Experience with radiopharmaceuticals and Class 7 shipments; weekend tracking may be required
- Experience working with CROs, CMOs, and external vendors
- High attention to detail, well organized, highly motivated
- Strong multitasking and prioritization, communication and interpersonal skills
- Planning and basic project management skills; ability to work independently or in a team
- Experience in FDA or regulated environments; knowledge of cGMP, GDP is a plus
- Calm under pressure and able to act with urgency
Education
- None beyond the listed qualifications; relevant degrees as specified in Basic Requirements
Additional Requirements
- Physical Demands/Travel: Office environment; minimal travel a few times per year