CLIA Director Job ID: req1467 Employee Type: exempt full-time Facility: ATRF: Other Location: 8560 Progress Drive, Frederick, MD 21701 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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. Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest. Position Overview: PROGRAM DESCRIPTION The Cancer Research Technology Program (CRTP) develops and implements emerging technology, cancer biology expertise and research capabilities to accomplish NCI research objectives. The CRTP is an outward-facing, multi-disciplinary hub purposed to enable the external cancer research community. A major focus of the CRTP is the NCI RAS Initiative with the goal to discover new therapeutic interventions against RAS-driven cancers. In addition, the CRTP hosts the Nanotechnology Characterization Laboratory (NCL) which performs and standardizes preclinical efficacy and toxicity testing of nanoparticles intended for cancer therapeutics and diagnostics, and the Antibody Characterization Lab (ACL) which characterizes monoclonal antibodies or other renewable affinity binding reagents for use in cancer related research. CRTP scientists also work collaboratively with intramural NCI investigators to provide research technologies and expertise. KEY ROLES/RESPONSIBILITIES The CLIA Director will support CMDL in the development of robust and cutting-edge genomic and proteomic assays used for molecular profiling of patient specimens. Current efforts utilize Sanger, microarray, NGS and gene expression profiling from formalin fixed paraffin embedded specimens, and Multiple Reaction Monitoring (MRM) mass spectrometric proteomic assays. * The CLIA Director will independently perform clinical duties and function as a collaborator with the Principal Investigators (PI) Oncologists * Will interact with assay development groups and contribute to efforts to keep technologies current and effective * Provides medical oversight of clinical evaluations necessary to conduct clinical laboratory studies in support of NCI/NIH sponsored trials * The CLIA Director will be directly involved in histological interpretation of patient derived samples for an ongoing project * Review results of germline and/or somatic NGS assays for validity * Will correspond with medical geneticists and oncologists on interpretation of data/results * Authors documents, reviews research and clinical protocols pertinent to this effort. Contributes to the development and refinement of protocol approaches and methods * Successfully perform in a highly matrix collaborative team 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: * Possession of an MD or PhD degree in Oncology or Molecular Pathology or related field, from an accredited college or university according to the Council for Higher Education Accreditation. Foreign degrees must be evaluated for US equivalency. * A minimum of ten (10) years of relevant experience * Eight (8) years leadership, management, supervisory experience * Training/experience in the field of oncology and/or molecular pathology. * In-depth understanding of quality metrics data for NGS platforms * Training/experience in the field of oncology and/or molecular pathology * In-depth understanding in molecular biology techniques, oncology and clinical research * Experience interpreting variants in the context of the medical literature * Experience interpreting mass spectrometric proteomic data, preferably in a clinical setting * Professional mastery of clinical research concepts and processes with knowledge/experience of molecular assays and expertise in clinical research protocol implementation and management and ability to perform genomic analysis using next generation sequencing tool * Proven track record of relevant publications * Background with federally regulated research grants, clinical trials or pharmaceutical projects * Working knowledge of Good Laboratory Practices (GLP) and CMS CLIA regulations (or equivalent regulatory programs, eg CAP) * Strong writing skills and ability to author documents including manuscripts for publications, SOPs, clinical protocols, etc. * Must be able to obtain and maintain a clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: * Experience with molecular biological assays, direct management experience, regulatory knowledge pertinent to CLIA or FDA guidelines for clinical assays * Experience with oncology and germline diagnostics including hereditary cancer syndromes * Excellent communication skills (written and oral) * Ability to work effectively in a team-oriented environment * Ability to identify and solve complex problems * Strong organizational and multitasking skills * Familiarity with patient derived xenograft and pre-clinical drug studies JOB HAZARDS * This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) #readytowork