Principal Scientist

Frederick National Laboratory
Frederick, MD
Oct 23, 2020
Oct 31, 2020
Full Time
Principal Scientist Job ID: req1028 Facility: Frederick: Ft Detrick Location: PO Box B, Frederick, MD 21702 USA The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases. Position Overview: PROGRAM DESCRIPTION The Frederick National Laboratory for Cancer Research (FNL) is sponsored by the National Cancer Institute (NCI) and operated by the prime contractor Leidos Biomedical Research, Inc. FNL is responsible for pursuing a unique mission in translational and applied biomedical research that is unsuitable for academia, the pharmaceutical industry, or other federal contractors. This open position in Pharmacodynamics is ideally suited for a scientist who is more interested in applied Research & Development than in pursuing basic research knowledge. However, the candidate must possess the needed interest, skills and motivation for translating scholarly knowledge in multiple scientific fields (pharmacology & therapeutics, chemical biology, biochemistry, cell biology and cancer pathobiology) into clinically-useful, high-performance measurements of experimental drug mechanism of action that will enhance and accelerate clinical development of new therapeutics for treating cancer. This open position provides a unique opportunity to collaborate with early clinical trial physicians, developmental therapeutics specialists, and drug discovery teams, all of whom depend upon robust, fit-for-purpose assays of pharmacodynamic biomarkers to inform drug development. The Clinical PD Biomarkers Program is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute. The scope of work includes assay design, development, validation, fitness for purpose testing, transfer of assays to clinical laboratories, and clinical specimen analysis when required. The program facilitates mechanistic evaluation of putative anti-cancer agents, diagnostic tests, and therapeutic interventions to facilitate clinical entry, including distinct molecular signatures for cancer, refined molecular assays, and state-of-the-art imaging techniques that are too high-risk for industry or academia to pursue. The program operates a number of advanced, specialized instrumentation for image analysis of tumor biopsies, circulating tumor cells, and activated T-cells for measuring drug effects in patients enrolled in phase 0 and 1 clinical trials. KEY ROLES/RESPONSIBILITIES * Provide scientific leadership in the development of valid fit-for-purpose assays of pharmacodynamic biomarkers * Provide strategic input into the PADIS assay portfolio * Provide technical leadership in identifying and implementing advanced quantitative analysis platforms, as applied particularly to image analysis, in support of clinical specimen analysis and studies of therapeutic mechanisms of action * Manage the clinical specimen analysis strategy and workflow on multiple platforms in a timely manner, delivering accurate, traceable results to the Clinical Team at NCI * Develop strategies and methods to integrate data from multiple clinical trials, collected on different analysis platforms, to inform best biomarker strategy for oncology drug candidates, and drug combinations, in Phase 0 and Phase 1 clinical trials * Manage a team of researchers, including PhD level scientists BASIC QUALIFICATIONS * Possession of a doctoral degree (eg, DSc, PhD) from an accredited college or university (according to CHEA) in biomedical research, biochemistry, chemistry, engineering or other related field of study. Foreign degrees will be evaluated for US equivalency * In addition to education requirements, a minimum of eight (8) years of competent, innovative research in the field of clinical diagnostics, pharmacology, high content image analysis and/or multiplex analysis of protein biomarkers, theragnostics, or similar discipline * Proficiency in biomarker study design and data analysis * Experience in managing multiple projects and delivering timely products and assay results * Knowledge of clinical trial designs and regulatory aspects * Experience in clinical specimen testing of tissues and cells * Experience in supervising or directing laboratory work in a GLP and/or CLIA environment * Experience in developing preclinical and validated clinical assays to demonstrate therapeutic mechanisms of action in patient tumor samples * Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS * Expertise in image analysis employed in validated assays for reporting results on human clinical specimens, including tumor biopsies * Demonstrated experience in methods for analysis of circulating tumor cells * Demonstrated experience in automated instrumentation * Demonstrated experience in monoclonal antibody development and protein chemistry * Demonstrated experience in multiplex analytical methods and validation processes * Demonstrated experience in specifying customization strategies for instruments and software that can then be applied to clinical specimens * A publication record, in the refereed scientific literature, of successful implementation of novel, quantitative biomarker assays in clinical specimen analysis, in diagnostics, pharmacology, toxicology, or related field 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 * This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)