Associate Director, Clinical Supply Chain

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients and contribute to the management of clinical drug supply chains.

Responsibilities

• Represent Clinical Supply Chain on the Clinical Study teams and other clinical related cross-functional meetings to ensure Clinical Trial Material supply milestones are met across all programs
• Support clinical demand activities for both on-going and new clinical trials. This includes demand forecasting, trial monitoring & resupply planning, label design, packaging vendor management activities, IRT set-up and distribution activities
• Accountable for clinical labeling, packaging and distribution
• Responsible for leading Clinical Supply Strategy Planning (CSSP) review meetings which captures CTM demands from Clinical Operations / Global Medical Affairs, reviews the bulk supply plan vs. aggregated clinical trial forecasts, addresses and mitigates program risks, and reviews current state of each protocol within a development program
• Will support the department budget including review & approval of vendor invoices, and monitoring planned vs. actual spend on both an assigned trial and program levels
• Develop root cause analysis and/or risk mitigation strategies and action plans to address any potential issues that may impact the integrity of the Clinical Supply Chain
• Provide leadership in the development and implementation of continuous improvement initiatives to improve lead-times, accelerate speed to customer, and reduce supply chain risks
• Work collaboratively with Clinical Operations, Quality Assurance, CMC and Regulatory Affairs to efficiently deliver clinical supplies as needed while ensuring compliance to all applicable laws and
• Partner & build relationships with Clinical Research Organizations (CRO’s) for effective utilization of drug supply materials
• Extensive vendor management, overseeing contributing third parties, Clinical Packagers, IRT vendors, Distribution Depots, etc
• Lead and mentor Clinical supply managers