Molecular Pathologist / CLIA Director - MoCha

Frederick National Laboratory, operated by Leidos Biomedical Research, Inc., addresses urgent and intractable problems in biomedical sciences including cancer, AIDS, drug development, nanotechnology in medicine, and emerging infectious diseases. The Molecular Characterization Laboratory (MoCha) is a dynamic team within the Clinical Research Directorate, dedicated to implementing cutting-edge genomic technologies to identify predictive biomarkers and improve patient lives through translational discoveries.

About the role

The successful candidate will serve as the CLIA Director for MoCha’s two CLIA laboratories, directly participating in the review of next-generation sequencing (NGS) and other clinical assay results and generating final patient reports. This role supports NCI-sponsored clinical studies, including clinical trial management, regulation, and protocol development for precision oncology initiatives such as ComboMATCH, iMATCH, and myeloMATCH. The position oversees the development and validation of new clinical assays and genomic technologies, contributes to the senior leadership team, and is expected to present findings at scientific conferences and publish in peer-reviewed journals.

Responsibilities

• Support R&D laboratory projects involving NGS and gene expression profiling from formalin-fixed paraffin-embedded specimens
• Lead assay development and analytical validation as needed
• Contribute to research focused on identification and verification of predictive biomarkers
• Represent the CLIA laboratories in regulatory meetings
• Support best practices for clinical testing and maintain CLIA compliance with assistance from the Quality Assurance group
• Independently perform pathology review duties
• Support histological verification of clinical specimens and histopathological analysis of patient-derived xenograft models for DCTD studies
• Present findings at scientific conferences and to NCI leadership; publish in peer-reviewed journals
• Supervise laboratory staff
• Collaborate with NCI colleagues and thought leaders to support translational studies conducted by NCI’s National Clinical Trials Network
• Mentor and develop junior scientists and staff in diagnostic assay development and translational research

Requirements

• Active, unrestricted medical license in a U.S. State, Territory, Commonwealth, or the District of Columbia (Maryland Medical License required upon acceptance of offer)
• Foreign degrees must be evaluated for U.S. equivalency
• Board certification in anatomic and/or clinical pathology
• Board certification in molecular pathology (required at time of offer acceptance)
• A minimum of three (3) years of experience directing or supervising high complexity testing in oncology and/or molecular pathology
• In-depth understanding of NGS assays and other common clinical/research platforms, including quality metrics, germline and/or somatic assay results, and variant interpretation
• Ability to perform genomic analyses using tools such as Integrative Genomics Viewer (IGV)
• Professional mastery of clinical research concepts and expertise in clinical research protocol implementation and management
• Familiarity with guidelines for clinical assay development (e.g., CLIA, NYSDOH, CAP, FDA)
• Ability to work effectively in a highly matrixed team environment
• Scientific leadership and direction for research projects
• Working knowledge of Good Laboratory Practices (GLP) and CMS CLIA regulations or equivalent standards programs (e.g., CAP)
• Ability to perform responsibilities of a Laboratory Director as specified in 42 CFR 493.1445
• Strong writing skills for manuscripts, meeting abstracts, posters, standard operating procedures, and clinical protocols
• Basic Microsoft Office skills
• Ability to obtain and maintain a security clearance

Preferred Qualifications

• Experience with molecular (e.g., RT-PCR) and protein-based clinical assays (e.g., IHC, IFA, mass spectrometry)
• Familiarity with patient-derived xenograft models and pre-clinical drug studies
• Experience with federally regulated research, clinical trials, and/or pharmaceutical studies
• Board certification in Laboratory Genetics and Genomics
• Prior experience managing and mentoring scientific staff

Skills

• Excellent written and oral communication skills
• In-depth understanding of commonly used molecular biology techniques, oncology, and clinical research
• Ability to work effectively in a team-oriented environment

Job Hazards

• Potential exposure to animals and/or animal materials
• Potential exposure to infectious material, requiring medical clearance and immunizations

Pay

The posted pay range for this full-time position is $181,200.00 - $259,582.00 USD. The range is a general guideline and not a guarantee of compensation. Additional factors considered include job responsibilities, education, experience, knowledge, skills, abilities, internal equity, and market data alignment.

Benefits

• Competitive compensation
• Health and Wellness programs
• Income Protection
• Paid Leave
• Retirement benefits