Associate Director, Temperature Strategy & Execution

Johnson & Johnson Innovative Medicine Research & Development (JJIM R&D), part of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Temperature Strategy & Execution within Clinical Supply Chain (CSC). The position can be located in Horsham, PA, Titusville, NJ, or Beerse, BE.

Within JJIM R&D, CSC holds the global responsibility for delivering all clinical supplies (Devices, API, Drug Product, Finished Kits) in the R&D portfolio. Our activities include all in-house and outsourced manufacturing, demand forecasting, supply planning, and global distribution of supplies to more than 145,000 patients in over 85 countries in more than 400 clinical trials every year.

As the Associate Director, Temperature Strategy & Execution, you will be responsible for leading a team, setting the strategic direction and the operational management of temperature-related matters for the worldwide distribution activities of clinical supplies for synthetics, biologics, vaccines and advanced therapies during all phases of clinical trials, consistent with GxP guidelines. You will develop and implement new solutions and make improvements to existing solutions and processes.

Key Responsibilities:

• Lead the Temperature Strategy & Execution (TS&E) team, modelling conscious inclusion and J&J Leadership Characteristics.
• Develop and recruit diverse talents.
• Accountable for TS&E processes, including Audits & Inspections, Temperature Excursion Assessment, and Temperature related base business escalations.
• Oversee TS&E governance within Clinical Supply Chain (CSC) and within partner organizations (i.e. Quality, Drug Product Development, Analytical Development, Global Clinical Operations).
• Ensure TS&E activities are consistent with all Standard Operating Procedures (SOP) and GxP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Pharma R&D
• Develop and lead future-state strategy for TS&E focused on enhanced processes, governance, and technology, in alignment with cross-functional stakeholders.
• Own requirements on how Clinical Supplies should be monitored and controlled during transit to and storage at Investigational Sites and Depots
• Accountable for passive shipper and temperature monitoring device strategy in CSC, including requirements, performance standards, evolution, and day to day oversight.
• Conduct TS&E as a center of excellence, addressing temperature management requirements for storage and transit of study drug.
• Develop strong internal collaboration with and influence functional and cross-functional stakeholders (including CSC, Commercial Quality, Deliver, Global Development, Drug Product Development, Analytical Development, Compliance, CSC QA) to ensure base business execution and anticipate upcoming needs and drive synergies when developing new capabilities.
• Support changes to the portfolio including new trials, strategies, modalities, licensing & acquisitions, and business integrations.
• Proactively apply data and metrics to drive continuous improvement and sponsor continuous improvement initiatives across the end-to-end logistics’ team.