Senior Molecular Pathologist & CLIA Lab Director

Frederick National Lab for Cancer Research; Frederick (MD); On-site; USD 181,000 - 303,000; Full time

Job summary

Frederick National Laboratory for Cancer Research is seeking a CLIA Director to oversee two CLIA laboratories, review NGS results, and generate final patient reports. The role supports NCI-sponsored trials (ComboMATCH, iMATCH, myeloMATCH) and oversees development/validation of new clinical assays, while contributing to scientific publications.

The candidate will lead regulatory interactions, ensure CLIA compliance, and mentor junior scientists within the CRD leadership team.

Qualifications

• Active, unrestricted medical license in the United States, its territories, or the District of Columbia; Maryland license after offer accepted.
• Board certification in anatomic and/or clinical pathology.
• Board certification in molecular pathology at time of offer.
• Minimum three years directing or supervising high complexity testing in oncology/molecular pathology.
• In-depth understanding of NGS assays, quality metrics, and variant interpretation.
• Ability to perform genomic analyses using NGS tools (e.g., IGV).
• Clinical research protocol implementation and management expertise.
• Familiarity with CLIA, NYSDOH, CAP, FDA guidelines for clinical assay development.
• Ability to work in a highly matrixed team environment.
• Strong writing skills for manuscripts, abstracts, SOPs, and protocols.
• Basic Microsoft Office skills; security clearance ability.

Responsibilities

• Support R&D projects involving NGS and gene expression profiling from FFPE specimens
• Lead assay development and, when needed, analytical validation
• Lead and contribute to research identifying and verifying predictive biomarkers
• Represent the CLIA laboratories in regulatory meetings
• Support CLIA compliance with QA group assistance
• Independently perform pathology review duties
• Support histological verification of clinical specimens and xenograft models
• Present findings at conferences and publish in peer‑reviewed journals
• Supervise laboratory staff
• Collaborate with NCI colleagues and translational researchers
• Mentor junior scientists and staff in diagnostic assay development
• Position is full-time onsite in Frederick, Maryland.

Skills

Medical license (unrestricted)

Board certification in pathology

Molecular pathology experience

NGS data analysis

IGV familiarity

Clinical research protocol management

CLIA/CAP/FDA guidelines

Laboratory leadership

Microsoft Office

Security clearance eligibility

Tools

IGV

Job description

Frederick National Laboratory for Cancer Research is seeking a CLIA Director to oversee two CLIA laboratories, review NGS results, and generate final patient reports. The role supports NCI-sponsored trials (ComboMATCH, iMATCH, myeloMATCH) and oversees development/validation of new clinical assays, while contributing to scientific publications.

The candidate will lead regulatory interactions, ensure CLIA compliance, and mentor junior scientists within the CRD leadership team.