Description:
In this role you will be responsible for planning Kits for the Pack & Tech and Distribution activities of Patient dosing to meet First-Patient-In (FPI) date and consistently meet Successful Patient Dose target throughout the lifecycle of a J&J R&D trial, within budget. Generally, the focus is on large, complex studies and compounds. The Kit Supply Planning process is a key input to the Clinical Supply & Operations Planning process (cS&OP).
Key Responsibilities:
- Transition planning activities from the Clinical Supply Integrator (CSI) in the study design phase.
- Provide Master Data (MD), configure distribution networks in the relevant Kit planning systems and set planning and inventory parameters with support from the Systems and Randomization Trial Supply Management (RTSM) team.
- Set and own the trial supply budget for P&T and Distribution and work with Logistics to ensure budgets are met or adjusted in relevant systems.
- Inform CSI of budget status, risks or significant changes, including rationale.
- Adapt supply strategies (SC configuration, planning parameters) in view of changes in trial execution or protocol.
- Develop supply strategies to meet clinical plans while optimizing drug overage.
- Ensure supply planning is adapted to the latest forecast recruitment rates and inventory strategy.
- Use business tools to set and actively manage inventory targets at depots and sites and provide guidance to Trial Supply Leaders (TSL) to ensure timely delivery with minimal overage of clinical supplies.
- Responsible for transparent communications to call out any study risks via the cS&OP process.
- Identify and develop scenario analysis to drive/support decision making through the cS&OP process.
- Collaborate with the management team via Executive cS&OP, with guidance from the Team Lead.
- Attend P&T Operations meetings to ensure P&T campaigns are GMP (Good Manufacturing Practices) released by the Quality group per the order target date.
- Work independently with limited coaching, and in situations of high workload.
- Support continuous improvement initiatives.
- Responsible for managing supply and inventory issues and resolutions at the study and compound level with some guidance.
Qualifications:
Education:
- A minimum of a Bachelor's degree is required. An advanced degree is preferred.
- APICS certificate in Production and Inventory Management is preferred.