Associate Director, Clinical Supply Integrator - Horsham Pennsylvania

Company: Disability Solutions
Location: Horsham, Pennsylvania
Posted On: 05/18/2024

Johnson & Johnson is recruiting for an Associate Director, Clinical Supply Integrator located in Horsham, PA; Titusville, NJ; or Beerse, Belgium. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . The Associate Director, is a matrix team leader responsible for the management of clinical supplies during the study execution phase of pharmaceutical R&D clinical trials, aligned per Therapeutic Area. This Clinical Supplies leader ensures the team manages the budget at a functional level and influences adherence to trial management processes, while proactively managing risk to avoid patient impact. Key Responsibilities:

• Study drug management for pharmaceutical R&D clinical trials.
• Ensure 99.5% successful dose, optimized inventory levels and campaigns and minimized SCRAP for the trial.
• Manage activities required to meet clinical trial protocol requirements including: demand forecasting monthly with cross-functional trial teams, distribution network planning, IRT issue identification and resolution, kit and label changes, develop supply strategies to meet clinical plans while optimizing drug overage, and manage study drug budgets ( OOP$).
• Influence decisions in therapeutic areas from a clinical supply chain perspective.
• Drives team accountability for issue investigation and resolution activities related to clinical trial supply.
• Represent Clinical Supply Chain for a particular trial and for various processes during GCP and GMP health authority inspections.
• Provide mentorship and support for team members on advanced concerns and interactions with the management team via Executive cS&OP.
• Support team to properly mitigate any study risks via the cS&OP process, while maintaining the highest standards of quality and compliance.
• Develop excellent working relationships with the other groups within Clinical Supply Chain (i.e. CSI, CSP, TM&C, Logistics, and Pilot Plants).
• Serve as CSC departmental lead in audits and inspections.
• Develop, sponsors and leads cross-functional and cross-departmental initiatives to improve business process/tools.
• Develop and implement functional ( TSM) and department (CSC) strategy.
• Champion and implement Discovery, Process Development & Supply and R&D Operations strategies.
• Ensures seamless conversion between Trial Supply Managers and provide oversight and support through execution as needed.
• Develop and manage the trial supply functional budget (internal FTEs as well as OOPs)
• Identify and leads innovative projects to significantly improve functional and cross-functional processes and tools. More...

      

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