You are responsible for executing the pack & label plan and distribution activities of patient kits to meet First-Patient-In (FPI) date and consistently meet Successful Patient Dose target throughout the lifecycle of a J&J Pharma R&D trial.
Manages the set-up activities required to meet First-Patient-In date of clinical trials. This includes retrieval of initial demand forecast, initiation of the clinical label, configuration of the distribution network and developing IRT specifications.
On an ongoing basis resolve supply related issues (e.g., packaging, distribution) and escalate to management if needed. Throughout the lifecycle of a trial utilize IRT to manage inventories at depots and sites, ensuring on-time delivery of clinical supplies for patient dosing and adapt supply strategies in view of changes in trial execution.
Develop strong internal collaboration with internal and external stakeholders.
Planning activities (demand planning, supply planning, inventory planning) could be required but are not a standard mission of the job.
Focus and scope
- Responsible for the management of all clinical supplies during trial execution
- Travel: 10%
- Minimum 80% FTE required
- Excellent written and verbal communication skills
- Strong project management and cross-functional coordination skills, able to build strong collaborative teams and relationships
- Foundational understanding of clinical trials and underlying dynamics to optimize global P&L and Distribution processes and interdependencies with Clinical Operations
- Strong attention to detail
- Ability to work independently with some coaching
- Ability to multi-task and manage complexity
- Ability to work in a high-pressure environment
- Solution oriented
- Integrity and Credo Based-actions
- A university/bachelor’s degree (or equivalent experience) and 4-6 years of experience preferably in a clinical supply related role
- General knowledge of GxP principles
- Experience with the following functions preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management
Specific know how of systems
- Experience with clinical supply demand management tools preferred (e.g., tcVisualize, IVRS, SAP, OMP+)
- Intermediate to advanced software skills (e.g., Microsoft Excel, OneNote, Powerpoint)
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)