Molecular Oncology & Clinical Genomics Consultant

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Summary

This Molecular Oncology & Clinical Genomics Consultant is a board-certified Clinical Molecular Geneticist with over 24 years of experience in molecular diagnostics, bringing extensive expertise in clinical test development, validation, regulatory submissions, quality systems, and operational implementation. Experience spans early-stage startups, mid-sized organizations, and large reference laboratories.

This Molecular Oncology & Clinical Genomics Consultant has held senior executive leadership roles, including CLIA Clinical Laboratory Director, Technical Supervisor, Clinical Consultant, and Scientific Director, with comprehensive oversight of both R&D and clinical laboratory operations. His work has encompassed laboratory build-out and scale-up, including workforce planning, hiring, workflow design, automation strategy, and alignment with provider and clinical needs.

This Molecular Oncology & Clinical Genomics Consultant has led cross-functional collaborations supporting reimbursement strategies, strategic partnerships, and commercialization efforts. His expertise spans molecular oncology, hereditary testing, carrier screening, companion diagnostics, and pharmacogenomics, with deep oversight of test development, validation, regulatory compliance (CLIA, CAP, NYSDOH), and clinical implementation.

This Molecular Oncology & Clinical Genomics Consultants experience includes a wide range of technologies, from traditional molecular assays to next-generation sequencing (NGS), with ongoing collaboration across bioinformatics, AI/ML, digital health, medical affairs, and commercial teams to advance innovative diagnostics into clinical practice.

Highlights

• 24+ years in diagnostic molecular testing (various technologies including NGS)
• Startup, mid-size, and large laboratories
• Experience in CLIA / CAP / State Regulations
• Clinical laboratory expertise: Molecular diagnostics (molecular oncology, hereditary genetic testing, pharmacogenomics), quality systems, workflow analysis, regulatory submissions
• Overseeing R&D, Validations, Proficiency Testing, Operations, Quality, and Clinical Test Service.

• Blood, tissue, liquid biopsy tests
• Business / Lab Management, Budgeting & Planning Experience
• ABMGG-Certified in Clinical Molecular Genetics
• New York State Certificate of Qualifications (CoQ) in Molecular Oncology and in Genetic Testing
• California Clinical Genetics Molecular Biologist Director License
• Working with commercial, medical affairs and pharma groups.

Relevant Accomplishments

• Helped startups build, validate and receive accreditation from CLIA, CAP and New York State.
• Oversaw validation and launch of new Laboratory Developed Tests and ensured that all activities were in full compliance with all regulatory requirements. Developed and validated extensive molecular oncology and genetics testing menus
• Operationalized extensive molecular testing menu using various technologies (PCR, fragment analysis, Realtime-PCR, NGS (Illumina, Ion Torrent), implementing automation and high-throughput workflows where needed.
• Developed quality assessment and quality assurance programs to ensure comprehensive monitoring of pre-, post-, and analytic processes thru measurement of key performance metrics, and establishing corrective and preventative action (CAPA) policies and procedures.
• Built R&D and clinical service testing teams for clinical case reviews and sign outs.
• Oversaw the overall operation and administration of a CLIA laboratory, ensuring that all duties were properly performed and applicable to CLIA regulations; Hired and maintained qualified personnel; Developed an effective quality system approach to laboratory testing that provided high accuracy and reliable patient test results.
• Developed and implemented the clinical, technical, fiscal, and quality programs of a diagnostic testing laboratory for corporation in a manner consistent with the needs of clinicians, customer hospitals and labs, and goals of the corporation.
• Acted as subject matter expert for molecular oncology and genetic testing, serving as technical supervisor and clinical consultant.

Roles

• CLIA Laboratory Director, R&D and Operations, Episteme Prognostics (fractional), Harbinger Health, Sema4
• Senior Vice President, Harbinger Health, Sema4
• Senior Scientific Director, Quest Diagnostics
• Consultant/Advisor, Episteme Prognostics, GraiMed, IO-Predict, Vitalex Biosciences

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