Scientist II Job ID: req1537 Employee Type: exempt full-time Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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 National Clinical Target Validation Laboratory (NCTVL) serves as a clinical pharmacodynamic biomarker validation and testing center for the NCI's Division of Cancer Treatment & Diagnosis (DCTD) and is a key component in the clinical pharmacodynamics (PD) program at the Frederick National Laboratory for Cancer Research. NCTVL works closely to convert newly developed and validated assays of biomarkers of drug mechanism of action into clinical assays, and works closely with NCI clinicians and investigators to use the validated clinical assays to analyze patient specimens from early clinical trials and report assay results to inform the trials and confirm drug mechanisms of action (MOA) of the investigational agents in patients. KEY ROLES/RESPONSIBILITIES * Plan, conduct, analyze and report on PD biomarker assessment of biopsy specimens using imaging technology platforms and instrumentations in the support of early clinical trials and fitness-for-purpose non-clinical studies (current technology platforms include quantitative immunofluorescence microscopy, imaging mass cytometry, and immunohistochemistry with digital image acquisition and analyses) * Work closely with assay development scientists in PD assay transfer, validation and harmonization activities * Lead NCTVL in PD testing support of preclinical and clinical studies including supervising research associates and data analysis and reporting * Assist lab director in managing lab R & D projects, QA, QC and reagent manufacturing BASIC QUALIFICATIONS * Possession of PhD degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a biochemistry, genetics, pharmacology, pathology or related field. Foreign degrees must be evaluated for US equivalency * In addition to educational requirements, at least 2 years of postdoctoral experience in cancer diagnostics, therapeutics, drug development, pharmacology, pharmaceutics, or other human disease related preclinical/clinical R & D projects * Experience using imaging techniques and technologies to quantify (measure) drug effects as part of an investigation into drug pharmacology and/or mechanism of action (MOA) * Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS * Immunofluorescent microscopy-based biomarker research and development experience * Immunofluorescent microscopy-based laboratory work on drug mechanism of action and/or measurement of drug effects in tissue specimens * Working knowledge and laboratory experience in anti-cancer drug mechanisms of action, including DNA repair, apoptosis and other cell death related pathways, or immuno-oncology related biomarker discovery and development, preferably with hands-on projects * Preclinical and clinical specimen process and testing experience * Experience with assay transfer & validation, critical reagent production/diagnostic reagent manufacturing * Successful working history in matrix organization for clinical lab support program * Experience using clinical assays within a regulated environment (eg, IND studies, CLIA, GLP/GMP environments) JOB HAZARDS * This position is subject to working with or have potential for exposure to animal(s) and/or animal material(s) * 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