Molecular Pathologist / CLIA Director - MoCha

BioSpace; Frederick (MD); On-site; USD 181,000 - 303,000; Full time

Job summary

Leidos Biomedical Research, Inc. in Frederick, Maryland, seeks a CLIA Director for the Molecular Characterization Laboratory (MoCha).

The role oversees two CLIA labs, reviews NGS results, and drives assay development and regulatory compliance within the CRD at the Frederick National Laboratory for Cancer Research. The candidate will lead senior research staff, contribute to presentations at conferences, and publish findings in peer-reviewed journals, supporting NCI-sponsored trials such as

Qualifications

• MD/DO with unrestricted license
• Board certifications in pathology and molecular pathology
• Experience directing high-complexity oncology/molecular testing
• Familiarity with CLIA, NYSDOH, CAP, FDA guidelines

Responsibilities

• Review NGS and clinical assay results and generate final patient reports
• Oversee development/validation of new clinical assays and genomic technologies
• Lead regulatory meetings and ensure CLIA compliance with QA support
• Supervise laboratory staff and mentor junior scientists
• Collaborate with NCI and translational research teams on assay development

Skills

Leadership

NGS analysis

Clinical research

Regulatory knowledge

Team supervision

Education

MD/DO

Board certification in pathology

Board certification in molecular pathology

Foreign degrees evaluated

Tools

IGV (Integrative Genomics Viewer)

Other sequencing platforms

Job description

Job ID: req4663
Employee Type: nonexempt full-time
Division: Clinical Research Directorate
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

Program Description

The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research’s Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research. Our laboratory consists of a dynamic team of over 40 scientific, informatics and support staff. For 14 years, MoCha has worked closely with the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) in support of DCTD-sponsored clinical trials and pre-clinical studies. We are dedicated to implementing cutting-edge genomic technologies to identify new predictive biomarkers and to make translational discoveries that will improve the lives of patients with cancer.

Key Roles/Responsibilities

The successful candidate will serve as CLIA Director of the Molecular Characterization Laboratory’s two CLIA laboratories, directly participating in review of next-generation sequencing (NGS) and other clinical assay results and generation of the final patient reports. This role will provide critical support for NCI-sponsored clinical studies to include clinical trial management, regulation and protocol development for the large NCI precision oncology initiatives ComboMATCH, iMATCH and myeloMATCH. The position will oversee the development and/or validation of new clinical assays and genomic technologies. The successful candidate will be part of the senior leadership team and expected to make substantial contributions to the overall success of the laboratory including presenting 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, when needed, analytical validation
• Lead and contribute to research focused on identification and verification of predictive biomarkers
• Represent the CLIA laboratories as part of regulatory meetings
• Support best practices for clinical testing and maintaining CLIA compliance, with support from the Quality Assurance group
• Independently perform pathology review duties
• Support histological verification of clinical specimens and the 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 with thought leaders to support translational studies conducted by NCI’s National Clinical Trials Network.
• Mentoring and developing junior scientists and staff in diagnostic assay development and translational research will be a key responsibility of this position

This position will be full-time onsite and located in Frederick, Maryland.

Basic Qualifications

• Active, unrestricted medical license in a State, Territory, or Commonwealth of the United States, or in the District of Columbia. Will be required to obtain State of Maryland Medical License once offer is accepted.
• Foreign degrees must be evaluated for U.S. equivalency
• Board certification in anatomic and/or clinical pathology
• Board certification in molecular pathology at time offer is accepted
• A minimum of three (3) years of experience directing or supervising high complexity testing in the field of oncology and/or molecular pathology
• In-depth understanding of NGS assay and other common clinical/research platforms including in the areas of quality metrics, germline and/or somatic assay results, and variant interpretation
• Ability to perform genomic analyses using NGS 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 successfully perform in a highly matrixed team environment
• Ability to provide 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 42CFR493.1445
• Strong writing skills and ability to author documents including manuscripts, meeting abstracts and posters, standard operating procedures, and clinical protocols
• Must possess basic Microsoft Office skills
• Ability to obtain and maintain a security clearance

Preferred Qualifications

• Experience with relevant 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

EXPECTED COMPETENCIES

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

JOB HAZARDS

• This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s)
• This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

181,200.00 - 303,250.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions