Senior Director of Clinical Supply Chain Management

2 days ago


Santa Clara, California, United States Bayside Solutions Full time
Job Summary

We are seeking a highly experienced Senior Director, Clinical Supply Chain to lead our team in planning and delivering clinical supplies to support our clinical development programs.

Key Responsibilities
  • Lead a team to plan and deliver on-time, compliant clinical supply per the clinical development plan.
  • Collaborate with cross-functional teams to proactively identify and mitigate potential risks to the continued advancement of the clinical programs.
  • Develop and manage the clinical supply plan for assigned programs.
  • Lead and manage clinical supply and logistics activities, including demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
  • Author, review, and approve related clinical and technical documents.
  • Lead vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution.
  • Serve as a Subject Matter Expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes.
Requirements and Qualifications
  • B.S. or M.S. in scientific fields with 15+ years of experience in clinical supply chain and logistics.
  • 5+ years of experience building and/or managing a clinical supply chain team.
  • Strong experience managing clinical supply activities for global phase 3 randomized oncology clinical trials.
  • Working knowledge of import and export laws and processes.
  • Working knowledge of pharmaceutical drug product development and manufacturing.
  • Solid organizational and time management skills.
  • Effective, open, and transparent communication skills.
  • Capable of working on multiple projects and tasks and able to meet deadlines.
  • Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

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