Associate Clinical Supply Chain Director

Associate Clinical Supplies Director

The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials. This individual also manages clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, and distribution operations at contracted manufacturing organizations (CMOs). The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.

Essential Duties And Responsibilities :

• Create and manage clinical forecast plans and budgets related to drug product, and clinical supplies for multiple programs and study levels, based on clinical study protocol and clinical development plans.
• Oversee the labeling, packaging, release, distribution and returns of clinical supplies at external CMOs for the assigned studies, maintaining budget and ensuring that the projects are delivered on time.
• Create global supply strategies, supply plans to support clinical studies; collaborate with Pharmaceutical Operations, Clinical Operations, Regulatory Affairs, Quality Assurance, and external vendors to execute the strategies for the clinical studies.
• Manage clinical trial supply to ensure timely IMP production; manage inventory and worldwide distribution activities; ensure uninterrupted supply.
• Manage label development process from generation of the master label text to label printing.
• Lead the development, review and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system.
• Co-lead the development of pharmacy documents, manuals and other tools with Clinical Operation team.
• Represent Clinical Supplies function at clinical trial team meetings; communicate plans and timelines to internal and external customers and partners.
• Utilize appropriate software and IT systems (e.g. IRT, MS Office, MS Project, Smartsheets, and others) to effectively manage key project activities.
• Provide coaching and guidance to team members.

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