Manager, Trial Supply Lead
Johnson & Johnson is recruiting for a Manager, Trial Supply Lead located in Titusville NJ, Horsham PA, Beerse BE. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Clinical Supply Chain (CSC) holds the responsibility of global clinical supplies of the Innovative Medicine Research & Development portfolio and the Global Medical Affairs portfolio. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product, Packaged and Labeled Clinical Supplies), demand forecasting, supply planning, and global distribution of supplies. Through a global network and organization we are responsible for the clinical supplies of Synthetics, Molecules and Bio Therapeutics and Advanced Therapies products in development and low volume commercial supply and secure the supply to more than 60.000 patients in more than 330 clinical trials every year.
Key Responsibilities:
- Execute 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 clinical trial.
- With limited or no guidance, manages the set-up activities required to meet First-Patient-In date of clinical trials. This includes:
- Retrieval of initial demand forecast from Global Development (GD).
- Initiation of the clinical label to support regulatory submissions.
- Configuration of the distribution network.
- RTSM specification development.
- On an on-going basis, throughout the lifecycle of a J&J clinical trial:
- Adapt supply strategies in view of changes in trial execution and ensure seamless transition from study design phase.
- Assess clinical study recruitment rates vs forecast, study assumptions vs. actuals, and determine where action needs to be taken, e.g. flag supply risk or budget impact.
- Utilize Demand Forecasting tools (eg, 4C Supply) to model trial demand.
- Utilize business tools (e.g. RTSM) to manage inventories at depots and sites, ensuring on-time delivery of clinical supplies for patient dosing.
- Establish and modify trial specific distribution agreements.
- With limited or no guidance, responsible for managing all aspects of supply related issue escalation and resolution at the study level. (e.g., packaging, distribution).
- Perform required quality reviews and close-out activities, storing appropriate documents in relevant systems.
- Manage trial supply budget.
- Member of appropriate Global Development(GD) clinical trial teams.
- Develop strong internal collaboration with the GD stakeholders to ensure customer satisfaction at both the trial and compound level.
- Develop excellent working relationships with the other groups within Supply Management .
- Functional subject matter expert within the team, acts as a coach and mentor within the team to drive technical and personal development.
- Challenges the status quo and contributes to initiatives to improve business processes and tools.
- Identifies and leads innovative projects to significantly improve functional and cross functional processes and tools.
- May lead cross-functional projects with broad CSC impact.
