Director of Clinical Lab Operations at Ultragenyx with 20+ years specializing in central laboratory operations and vendor management.
CENTRAL LAB EXPERTISE:
• 15 years at ICON Central Laboratories
• Progressed from Project Manager to Team Lead to Director of Project Management
• Managed global lab operations across North America, Europe, APAC
• Oversaw hundreds of clinical trials across all phases
SPECIALIZED IN:
• Central lab vendor selection & RFP processes
• Sample management & biosample operations
• Lab contract negotiation & performance management
• Quality oversight & regulatory compliance (ICH-GCP)
• Lab budgets (often identify 20-30% savings)
• Troubleshooting lab vendor issues mid-study
THERAPEUTIC EXPERIENCE:
• 8 years Oncology trials
• 4 years Vaccines
• 3 years Respiratory diseases
WHO I HELP:
• Biotech founders selecting their first central lab
• Clinical ops teams troubleshooting vendor problems
• Companies switching labs mid-study
• Professionals breaking into central lab careers
I've been on both sides: working inside a central lab (ICON) and managing labs as a sponsor (Ultragenyx). I know what labs can and can't deliver, what's negotiable in contracts, and where companies waste money.