Leah White

About Leah White

I have over 20 years of clinical research experience, encompassing target discovery to post-market guidance across pharmaceuticals, devices, biologics, digital health, and diagnostics. I embrace innovative ideas and understand that balancing strategy with creativity is key to success in experimental roles. My diverse background includes work in non-profit, governmental, and for-profit organizations.My therapeutic experience includes infectious diseases, respiratory illnesses, neurological conditions, cardiovascular medicine, pediatric cardiology, hematology, gastrointestinal diseases, Alzheimer\'s, and biomedical specimen registries.I have successfully initiated and secured funded clinical research projects and established necessary processes for their success. My skills include developing standard operating procedures, EDC, protocols, and study documents; negotiating contracts; training staff; and managing quality control. I am committed to continuous learning in research governance and enjoy training others in GCP and daily operations.

Experience

1. Associate Director of Good Clinical Practice

   Cartesian Therapeutics

   Oct 2025 — Present · Frederick, MD, US

   Audit current and previous clinical trial practices to make Good Clinical Practice recommendations for their mRNA CRT autoimmune therapiesLed the External Audit Program, including planning, executing, and reporting audits of clinical sites, CROs, and thirdparty vendors. Provided comprehensive clinical trial oversight to ensure adherence to GCP and regulatory expectations across all phases of development.Planned and prepared for FDA Biologics License Application and Investigational New Drug ApplicationRevised SOPs and Clinical Operations Practices Develop product wide quality assurance metrics tracking mechanisms Developed quality assurance GCP processes

Education

• Northwest Ohio Consortium for Public Health

  Master of Public Health (MPH), Public Administration

  2004 — 2005

• Bowling Green State University

  Bach of Science, Applied Health Science

  2000 — 2004

Skills

• Life Sciences
• Bioethics
• Internal Audit
• Biotechnology
• Project Coordination
• Nonprofits
• Healthcare Information Technology
• Quality Management
• Statistics
• Healthcare Management
• Microsoft Word
• Irb
• Standards Development
• Project Management
• Customer Service
• Large Budget Management
• Data Analysis
• Clinical Study Design
• Protocol Design
• Policy
• Contract Negotiation
• Protocol
• Microsoft Excel
• Powerpoint
• Hospitals
• Financial Analysis
• Clinical Trials
• Gcp
• Budget Reconciliation
• Training
• Medical Devices
• Clinical Research
• Public Speaking
• Regulatory Submissions
• Grant Writing
• Management
• Program Development
• Medical Education
• Analysis
• Budgets