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Summary
This experienced Clinical Services Director / consultant for clinical R&D and health systems development, including both global diagnostic medical testing and virology research in avian influenza A and coronavirus (MERS-CoV). He has experience in laboratory capacity building utilizing advanced serologies including PCR, as well as implementation of POC (iSTAT) testing across military healthcare facilities. He has experience with CLIA / CAP/ ISO15189/ State regulations, laboratory operations and management, assay validation, and Quality Assurance program development and practice.
He has extensive business operations experience including budgeting, labor forecasting, hiring, staffing, workflow planning and business plan development for laboratory rollout plans, including laboratory expansion projects.
Highlights
• Board-certified clinician
• 20+ years healthcare administrative and clinical services experiences
• New laboratory Services Rollout experience
• Extensive federal health and interagency experience (DHHS/NIH/CDC, DOD, USAID; contracting vehicles)
• Domestic and global Phase 1-4 biotech and pharma R&D experience
• Experienced in CLIA / CAP / ISO15189/State Regulations
• Clinical Laboratory experience: molecular diagnostics (infectious disease testing), immunology, clinical chemistry, flow cytometry, and mass spectrometry technologies
• Local-to-national scale multi-site lab management & planning experience
• Extensive population health data collection, analytics, and outcomes reporting experience
• Experience with federal and private industry biosurveillance stakeholders
• Experienced with direct FDA interface and collaboration (clinical safety data monitoring, protocols, etc.)
• Infectious Diseases experience (influenza, CoV, rotavirus, ebola, malaria, TB, etc.)
• Vaccine development experience
Relevant Accomplishments
- Knowledge of FDA Emergency Use Authorization (564) process from federal CBRNE experience; Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) and Emergency Use Authorization of Medical Products and Related Authorities (2017).
- Phase 4 post marketing surveillance, data aggregation and analysis, and reporting
- Within R&D roles, augmented existing and established new start-up clinical labs, from the ground up through CLIA, COLA, and CAP accreditation for global partners.
- Optimized, validated, and launched novel Laboratory Developed Tests (PCR; iSTAT).
- Developed quality assessment programs to ensure comprehensive monitoring of pre-, post-,and analytic processes to monitor testing performance and detect issues in a timely manner and develop effective corrective action plans when necessary.
- Ensured duties were properly performed and applicable to CLIA/CAP regulations; hired and maintained qualified personnel; developed an effective QA approach to laboratory testing that provided high accuracy and reliable patient test results.
- Ensured duties were properly performed and applicable to CLIA/CAP regulations; hired and maintained qualified personnel; developed an effective QA approach to laboratory testing that provided high accuracy and reliable patient test results.
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To apply for this job email your details to dmagnani@maexecsearch.com
