Molecular Pathologist / CLIA Director - MoCha

Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. and addresses urgent and intractable problems in biomedical sciences, including cancer, AIDS, drug development, nanotechnology in medicine, and emerging infectious diseases.

About the Role

The Molecular Characterization Laboratory (MoCha), part of Leidos Biomedical Research’s Clinical Research Directorate, is a dynamic team of over 40 scientific, informatics, and support staff. MoCha collaborates with the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) to support clinical trials and pre-clinical studies, implementing cutting-edge genomic technologies to identify predictive biomarkers and improve patient outcomes.

Responsibilities

• Serve as CLIA Director for MoCha’s two CLIA laboratories, reviewing next-generation sequencing (NGS) and other clinical assay results and generating final patient reports.
• Provide critical support for NCI-sponsored clinical studies, including clinical trial management, regulation, and protocol development for precision oncology initiatives (ComboMATCH, iMATCH, myeloMATCH).
• Oversee development and validation of new clinical assays and genomic technologies.
• Support R&D 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 identifying and verifying predictive biomarkers.
• Represent CLIA laboratories in regulatory meetings and support best practices for clinical testing and CLIA compliance.
• Perform pathology review duties, including histological verification of clinical specimens and histopathological analysis of patient-derived xenograft models.
• Present findings at scientific conferences and to NCI leadership; publish in peer-reviewed journals.
• Supervise laboratory staff and collaborate with NCI colleagues and thought leaders on translational studies.
• 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 license required post-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).
• 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, quality metrics, germline/somatic assay results, and variant interpretation.
• Proficiency in genomic analyses using tools like Integrative Genomics Viewer (IGV).
• Expertise in clinical research concepts, protocol implementation, and management.
• Familiarity with clinical assay development guidelines (e.g., CLIA, NYSDOH, CAP, FDA).
• Ability to work in a highly matrixed team environment and provide scientific leadership.
• Working knowledge of Good Laboratory Practices (GLP) and CMS CLIA regulations or equivalent standards (e.g., CAP).
• Ability to perform Laboratory Director responsibilities as specified in 42CFR493.1445.
• Strong writing skills for manuscripts, abstracts, posters, SOPs, 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, or pharmaceutical studies.
• Board certification in Laboratory Genetics and Genomics.
• Prior experience managing and mentoring scientific staff.

Skills

• Excellent written and oral communication.
• In-depth understanding of 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 materials, 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 may vary based on job responsibilities, education, experience, knowledge, skills, internal equity, and market data.

Benefits

Competitive compensation packages include Health and Wellness programs, Income Protection, Paid Leave, and Retirement benefits.