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 (FNLCR). The MoCha Laboratory is responsible for providing high-level research in support of the NCI-Cancer Diagnostics Program (CDP) within the Division of Cancer Treatment and Diagnosis (DCTD). MoCha is charged with the development and application of genomic assays for use in medical research and diagnostics for DCTD-sponsored national extramural clinical trials.  MoCha is comprised of several laboratory (research and clinical) units which include two CLIA accredited laboratories.

KEY ROLES/RESPONSIBILITIES

• Support DCTD in their initiative to establish robust and cutting-edge molecular assays for genomic and digital spatial profiling of patient specimens
• This position will serve as an associate director of CLIA laboratories at the Molecular Characterization Laboratory, directly participating in review of next generation sequencing (NGS) and other types of molecular clinical assay results and in the final approval of patient reports
• The position will also serve to support best practices for clinical testing and maintaining CLIA compliance, with support from the Quality Assurance Group
• 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 laboratory as part of regulatory meetings
• Develop analytical validation plans and guide staff in assay development and analytical validation activities
• Independently perform pathology review duties
• Function as a collaborator and consultant with NCI/NCI cooperative group Principal Investigators in support of NCI-sponsored clinical studies
• Interact with external assay development groups in development and management of sub-contracts and contribute to internal efforts to keep technologies current and effective
• Provide medical oversight of clinical evaluations necessary to conduct clinical laboratory studies in support of DCTD/Cancer Therapy Evaluation Program (CTEP) sponsored trials
• Support the histological verification of clinical specimens and the histopathological analysis of patient-derived xenograft models for DCTD studies
• Author documents including manuscripts and validation reports, review research and clinical protocols, present data at internal and external meetings and contribute to the development and refinement of protocol approaches and methods 
• This position will be located in Frederick, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Board certification in anatomic/clinical pathology
• Board eligible/certification molecular pathology
• Current professional license in Medicine 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. Completion of medical residency and/or fellowship in applicable specialty area as designated by the Program requirements. Board certified in applicable specialty area or equivalent clinical experience (according to CHEA)
• A minimum of one (1) year of relevant experience
• Training/experience in the field of oncology and/or molecular pathology
• In-depth understanding of NGS assay and other common clinical/research platforms including: experience with quality metrics data, review of germline and/or somatic assay results for validity, interpretation of variants in the context of the medical literature (experience with oncology and germline diagnostics including hereditary cancer syndromes desired).
• Ability to perform genomic analyses using NGS tools such as Integrative Genomics Viewer (IGV)
• Correspondence with medical geneticists and oncologists in the interpretation of NGS results 
• Professional mastery of clinical research concepts and expertise in clinical research protocol implementation and management
• Ability to successfully perform in a highly matrixed collaborative team
• Ability to lead research projects
• Proven track record of relevant publications
• Background with federally regulated research, clinical trials and/or pharmaceutical studies
• Working knowledge of Good Laboratory Practices (GLP) and CMS CLIA regulations (or equivalent regulatory programs, e.g. CAP)
• Strong writing skills and ability to author documents including manuscripts for publications, SOPs, clinical protocols etc.
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Regulatory knowledge pertinent to CLIA or FDA guidelines for clinical assays
• Experience with relevant molecular (e.g. NGS, RT-PCR) and protein-based clinical assays (e.g. IHC, IFA, mass spectrometry etc) is highly preferred

EXPECTED COMPETENCIES

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

JOB HAZARDS

• This position is subject to working with or having potential for exposure to infectious material, requiring medical clearance and immunizations

Pay Range $151,480.70 - $302,961.42

The Leidos Biomedical Research range for this job level is a general guideline only 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, alignment with market data, applicable bargaining agreement (if any), or other law.