Manager-clinical Trial Distribution Material

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.

The CT Supply Planning Organization is accountable for the development of molecule/study demand forecasts in partnership with the clinical team and the subsequent implementation of the supply plans. Additionally, the Supply Planning organization is accountable for the timely supply of New Drug Product and Finished Goods to internal and external partners. This will be accomplished by planning and scheduling via an MRP system (SAP). CT Distribution has the responsibility to ensure that CT materials are delivered from suppliers and moved all the way to the sites/hubs/depots in a FFU condition and on-time.

In order for this to happen you must have a global network of qualified hubs and depots with good processes, quality oversight, solid management and oversight, continuous improvements, sustainable cost structure and responsive to environmental changes. Additionally, you must have people managing the large number of transactions that are flowing through the systems and ensuring flawless daily execution.

Distribution will have two groups of staff for each zone that will manage these different variable and fixed components. The Distribution Buyer/Planner(s) and the Distribution Material Coordinator(s) will work together to manage the daily transaction piece (variable work) and the exception management processes that flow from more than 1200 annual bulk shipment orders and 60,000 to 80,000 site shipment orders. The Distribution Buyer Planner in cooperation with the Distribution Material Coordinator (DMC) will manage the infrastructure (fixed components) of the operations to ensure that the transactions can occur flawlessly each day. The DMC will be accountable for the movement of finished goods as from reception from the packaging plant to the hub(s) and for hub to hub and hub to depot movement. The DMC will also be responsible for general oversight of all material movement to sites from Hubs and Depots. Our Collaboration Partners generally manage this well but exceptions occur regularly requiring immediate intervention and decision making that have patient and CT material implications. In addition, they will be required to lead or participate in special projects supporting the development and implementation of distribution strategies related to products and capacities. The Distribution Buyer/Planner will be accountable for managing and overseeing all plants that they are assigned. They will also have responsibility to work with the other buyer/planners to ensure harmonization within and between zones and plants across the globe. They will be responsible for all activities for their plants including: strategy, staff, budgets, communications, Hub and Depot networks, processes in and between zones, relationship with vendors and overall quality.

The Distribution Buyer / Planners have a staff of Distribution Material Coordinator (s).

Key Responsibilities:

- Partners with the FING Distribution Plant Buyer/Planners and CTSM to understand delivery schedule and priorities; partners with quality, Clinical and hub/depot for delivery execution activities
- Monitors CT-WIN and/or SAP deliveries due list for all shipments
- Resolves issues with hub/depot and manages deviation investigations related to all shipments as needed
- Approves Quality Notification Forms from CPs
- Create ICI when needed
- Accountable for shipping documentation availability with hub/depot; Ensure completion of any pre-shipment paperwork and ensures necessary import approvals are in place prior to shipment execution
- Ensures execution of the delivery in-time to meet the demands at the receiving plant
- FFU determinations in case of temperature excursion
- For non-CT-WIN depots, monitor the receipt of periodic delivery data; periodic inventory reconciliation
- Identify related errors between CT-WIN and SAP
- Understands LRL Financial policies as they relate to CT Material and/or Investigational Devices and commercial pricing
- Author deviations and change controls and perform investigations as necessary to address departures from SOPs
- Ensure all internal and external regulatory requirements are met for Importation, warehousing, labelling and distribution activities for all type of products
- Participate or co-lead cross zone communication meetings
- Participate in the Metrics review meetings with the zone and distribution leadership
- Participate in the Metrics review meetings with couriers
- Participat