Lead, Clinical Supply Chain Planning

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.

Organization Overview:

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 39,000 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 people around the world. #WeAreLilly

Position Summary:

Reporting to the Sr. Director of Clinical Supply Chain, the Lead, Clinical Supply Chain Planning role will have functional responsibility for:

• Working with the clinical operations team, plan and schedule clinical batches with the internal manufacturing group and / or CMOs to ensure continuous supply of ‘just- in-time’ radiopharmaceuticals for clinical programs

• Observe, optimize and track the distribution of clinical products to ensure timely delivery to global clinical sites

• Ensuring shipments are performed according to local rules / regulations and proper documentation is in place

• The position is remotely based within North America, preferably within the Eastern Standard Time Zone  

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 (example RAM licenses, site information data base, 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 

• Plays a critical role in developing and maintaining 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 

• Provide verbal and written reports to manager in a clear and concise manner 

• Maintain accurate and complete supply chain tracking logs (Excel format) 

• Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.

• Contribute to the development and approval of supply chain procedures for clinical programs

• Embody and promote a quality culture and “right-first time” approach as part of all activities.

• Plays a critical role in developing and maintaining good relationships with partners, CROs, CMOs, vendors and suppliers.

• Work well in a fast-paced team environment.

• Perform other duties as assigned.

Basic Requirements:

• 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.

• Must be available to be on-call outside of core business hours to support issues that may come up during weekend deliveries. Frequency will be based on production demand.

Additional Preferences:

• Early start time (5am ET) may be required to support supply chain for EU clinical sites – this will depend on clinical trial timelines.

• Experience working with IWRS (Interactive Web Response System) IP ordering platforms considered an asset.

• Experience working with MRP / ERP considered an asset.

• Experience working with radiopharmaceuticals and Class 7 shipments will be considered an asset but is not a requirement. Note that weekend tracking of packages for delivery will be required due to the short shelf-life of radiopharmaceuticals.

• Experience working with CROs, CMOs, and/or external vendors and suppliers.

• High attentio