Precision Oncology & Molecular Diagnostics Consultant

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Summary

This Precision Oncology & Molecular Diagnostics Consultant is a board-certified Clinical Laboratory Director (DABMGG, CGMBS, HCLD) with over 20 years of experience driving research, development, and clinical diagnostic excellence. He possesses deep expertise in oncology and cancer genomics, with a specialized focus on nucleic acid-based assays (RT-PCR, ddPCR, NGS) for inherited and acquired disorders. In his current role directing a high-complexity laboratory, this Precision Oncology & Molecular Diagnostics Consultant leads assay development, evaluates clinical study designs, and reviews analytical data. He is a recognized expert in regulatory compliance (CLIA, CAP, NYS CLEP, FDA) with a proven track record of commercializing LDTs and IVDs

Highlights

• 20+ years in diagnostic medical testing  

• Oncology Assay Development & Cancer Genomics 

• Expert in CLIA / CAP /State Regulations 

• Clinical Laboratory expertise: Molecular diagnostics, (PCR / NGS / digital PCR) 

• Clinical Data Validation, Review, & Sign-outs 

• Fractional / Consulting Lab Director Experience 

• Clinical Study Design & Performance Assessment

• ABMGG and HCLD (ABB) Certified Certified; qualified to direct high complexity medical diagnostic laboratories 

• New Laboratory Services Rollout experience 

• Molecular Biology 

    Assay Development 

• Expert in CLIA / CAP / FDA Regulations 

• Quality Assurance (QA) & QC Protocol Development 

• Regulatory Submission Prep (FDA/EUA/NY-CLEP)

Relevant Accomplishments

• Technical & Scientific Leadership: Provided technical and scientific direction for 16 clinical laboratories from the ground up, successfully securing CLIA, COLA, and CAP accreditations. Led research and development initiatives, guiding cutting-edge diagnostic products from initial concept to full-scale clinical production while training and managing highly qualified scientific personnel. 

• Assay Development & Innovation: Spearheaded the design, optimization, validation, and launch of novel Laboratory Developed Tests (LDTs) across molecular diagnostics, oncology, and genetics. Pioneered advanced testing methodologies utilizing multiplex RT-PCR, ddPCR, and NGS. Directed the development of customized Laboratory Information Management Systems (LIMS) and NGS analytical pipelines in close collaboration with engineering teams. 

• Quality Assurance & Compliance: Provided comprehensive regulatory oversight by designing robust quality management systems for pre-analytical, analytical, and post-analytical processes. Ensured strict adherence to CLIA/CAP standards, implemented rapid corrective action plans, and maintained the highest accuracy in patient testing. 

• Clinical Data Analysis & Reporting: Interpreted complex sequence variants and performed clinical sign-outs in strict accordance with ACMG/AMP guidelines. Synthesized published literature, functional data, and in silico metrics to deliver accurate variant assessments and comprehensive diagnostic reports.
• Subject Matter Expertise: Served as the lead clinical and technical expert across oncology, reproductive genetics, carrier screening, and functional medicine. Successfully aligned laboratory capabilities with the strategic goals of the corporation and the practical needs of clinicians and hospital networks.

Roles

• High-Complexity Clinical Laboratory Medical Director 

• Chief Science Officer (CSO) 

• Clinical Laboratory Director / CLIA Director  

• Head of R&D, Quality, and Compliance 

• Director of Genetics & Genomics Laboratory 

• Chief Technology Officer (CTO) 

• Clinical Molecular Geneticist & Senior Scientist 

• Assistant Professor 

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