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Summary
This Clinical Laboratory Director is a Board-Certified High-Complexity Clinical Laboratory Director with over 10 years of experience in molecular diagnostics, clinical genomics, and laboratory leadership. His background includes directing and managing laboratory operations, overseeing assay development and validation, and ensuring quality and compliance across a range of diagnostic testing environments.
This Clinical Laboratory Director has held leadership roles spanning laboratory operations, research and development, quality, and regulatory functions, with experience supporting the development and implementation of molecular diagnostic assays across applications including oncology, genetics, infectious disease, and population screening. His technical expertise includes a wide range of nucleic acid–based technologies, including PCR-based methods and next-generation sequencing (NGS).
This Clinical Laboratory Director is experienced in clinical data review, genomic variant interpretation, and laboratory quality systems, and has contributed to the development and launch of laboratory-developed tests and diagnostic services. He has also been involved in clinical trial activities, laboratory expansion initiatives, and cross-functional leadership across scientific and operational teams.
Highlights
- 10+ years of experience in molecular diagnostics and clinical laboratory leadership
- Experience across CLIA, CAP, NYS CLEP, and FDA-regulated environments
- Technical expertise in PCR (RT-PCR, multiple PCR, digital PCR) and NGS(WES, WGS, gene panels)
- Background in oncology, genetics, infectious disease, and population screening applications
- Experience in assay development, validation, and laboratory implementation
- Clinical trials, study planning, and validation activities
- Clinical data review, variant interpretation, and reporting
Relevant Accomplishments
- Served as a Clinical Laboratory Director and technical leader, overseeing laboratory operations, assay performance, and compliance with regulatory standards
- Contributed to the development and validation of molecular diagnostic assays, including PCR- and NGS-based tests across oncology, genetic, and infectious disease applications
- Participated in clinical trial planning and execution, including development of study protocols, validation plans, and supporting documentation
- Performed clinical data analysis, genomic variant interpretation, and report generation, ensuring accuracy and adherence to established guidelines
- Supported the launch and expansion of multiple clinical laboratories, including development of workflows, SOPs, and quality processes
- Led and implemented quality assurance and compliance programs, including pre-analytical, analytical, and post-analytical processes
- Oversaw laboratory staff recruitment, training, and performance management, supporting the development of multidisciplinary teams
- Contributed to product development initiatives, including assay design, workflow optimization, and introduction of new diagnostic capabilities
- Participated in process improvement efforts, including workflow automation and turnaround time optimization
Roles
Clinical Laboratory Director, CSO, Head of R&D, Quality & Compliance, Shield T3 Health
• Laboratory Director, Vikor Scientific
• Director of Genetics & Genomics Laboratory / CTO, Arbor Diagnostics & Double Helix Management
• Clinical Molecular Geneticist & Senior Scientist, GeneDx
• ABMGG Clinical Fellow, Icahn School of Medicine at Mount Sinai
• Assistant Professor / Research Investigator (Cancer Genomics), University of California, Berkeley
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To apply for this job email your details to haleymmagnani@gmail.com
