Frederick National Laboratory for Cancer Research

Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Jan 25, 2020
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Clinical Monitoring Research Program Directorate (CMRPD) provides clinical program administrative support to the clinics operated by the Office of the Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI) at the National Institutes of Health (NIH). Assists with the administration of the complex clinical program and ensures major components and initiatives in the areas of patient care, clinical research staff recruitment, training and resource management are well integrated and move forward efficiently and effectively Interacts with various internal and external groups to facilitate clinical trials research and develop administrative procedures Acts as a liaison between outpatient clinics, the Clinical Center and other departments Identifies solutions for day-to-day problems by adapting processes and procedures with consideration to the coordination of patient care Assists in monitoring, control and reporting on clinical budgets Develops project timelines and tracks the progress of clinical projects Prepares reports and reviews sections of submissions, abstracts and presentations Special projects Develops project timelines Tracks progress, and monitors/prepares budget operating reports Works in conjunction and collaboration with NCI academic clinical scientists, research investigators and/or groups that participate in clinical research trials or influence clinical research Responsible for implementing operating guidelines utilizing standard NCI Policies and Standard Operating Procedures (SOPs) Reviews operational requirements for development of or changes to staffing All assignments and tasks are performed independently; however unusual or difficult problems are referred for review to the Administrative Director Supervises other administrative clinical support staff This position is located in Bethesda, Maryland BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university with course work related to clinical sciences or four (4) years related experience in lieu of degree Foreign degrees must be evaluated for U.S. equivalency A minimum of six (6) years of responsible administrative experience in a hospital or medical environment, including one (2) years in a supervisory capacity Experience should include work with protocols, clinical site management, data collection and analysis Must possess general knowledge of clinical trial fieldwork concepts and practices, regulatory requirements and guidelines for clinical research and monitoring requirements Must be well versed in Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs) Must be able to perform project management-type tasks for multiple clinical research protocols Must be able to obtain and maintain a clearance PREFERRED QUALIFICATIONS Familiarity with State Department Regulations and FARs
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 23, 2020
Full time
The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research's Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research. 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. KEY ROLES/RESPONSIBILITIES The Scientific Project Manager will be responsible for managing multiple projects in coordination with other scientific and project management staff. Specific duties will include: Provide scientific and administrative project management support Work directly with the NCI Project Manager(s) to ensure the scientific requirements for the project(s) are clear and being converted appropriately at LBR Meet requirements from the Project Management Office (PMO) for scheduled updates, including risk factors and finances Provide regular written reports detailing progress against tasks and milestones Work with Project Management staff to ensure the operational needs of the project are being met Draft technical requirements to be included in Statements of Work, New Work Packages, and proposals written in response to NCI task orders Utilize scientific expertise to review and approve subcontractor invoices Work directly to manage subcontracts to assure project execution Develop scientific protocols to be used as a guide for the project workflow Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, etc. Lead oral presentations and meetings with internal and external stakeholders Report research data, including presentations and/or scientific publications when needed Maintain a knowledge of the most recent literature and scientific presentations relevant to projects This position will be located in Frederick, Maryland. As a critical member of the MoCha Lab, on site presence will be required in Frederick and occasionally in Shady Grove, Maryland. BASIC QUALIFICATIONS Scientific Project Manager I: Possession of a PhD in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency Scientific Project Manager II: Possession of a PhD in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency Five (5) years progressively responsible experience in program/project management. Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level Both levels require: Experience with molecular biology assays, next generation sequencing, and cancer biology Experience with scientific technical writing and documentation Experience with budgeting, cost estimates, and financial projections Experience interpreting and/or authoring Statements of Work (SOW) Must have exceptional communication skills with ability to communicate clearly with all levels of scientific personnel and administrative staff through written and oral presentations Ability to multi-task and effectively prioritize and meet timelines in multiple concurrent projects Ability to work independently in a dynamic environment and capable of completing tasks with minimal supervision Scientific competency in a field relevant and related to cancer research Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Regulatory knowledge pertinent to CLIA or FDA guidelines for clinical assays Familiarity with patient derived xenograft and pre-clinical drug studies Familiarity with clinical trials Project Management Professional (PMP) certification EXPECTED COMPETENCIES In‐depth understanding of molecular biology techniques, oncology and clinical research Excellent communication skills (written and oral) Ability to work effectively in a matrix and team‐oriented environment Ability to identify and solve complex problems Strong organizational and multitasking skills Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 23, 2020
Full time
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 Provide cell biology support to the FNL/NCI RAS Initiative and work closely with a highly collaborative multidisciplinary team of chemists, biochemists, biophysicists, and structural/cell/molecular biologists to develop and optimize pharmaceutical agents for use as RAS inhibitors Develop and execute on strategies to evaluate drug activity and mechanism Design and execute experiments; accurately record, analyze, and present data to the team/senior leadership Develop assays and identify technologies to address key questions and drive the drug discovery process BASIC QUALIFICATIONS Possession of a PhD from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in molecular or cell biology, pharmacology, molecular toxicology or similar discipline. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. No work experience is required beyond the education requirements Strong expertise in cancer cell biology, drug discovery approaches, and cell-based assays Strength in designing and performing experiments to measure target engagement, pathway modulation, and therapeutic sensitivity in response to compounds Experience in Western blotting, real-time PCR, immunoprecipitation, siRNA/shRNA, PPI assays (co-immunoprecipitation, nanoBRET) Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS 2 years of post-doctoral research Expertise in the design and execution of molecular biological and biochemical or cellular experiments to determine the effects of therapeutics on biological systems Understanding of the drug discovery process from relevant pharmaceutical experience Experience in protein:protein interaction (e.g. HTRF or BRET) assay design and development Experience working with RAS proteins, understanding RAS biology Able to balance workload over multiple projects Excellent communication and interpersonal skills Ability to work independently and collaborate in a fast-paced team environment JOB HAZARDS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 23, 2020
Full time
Frederick National Laboratory is dedicated to improving human health through the discovery and innovation in the biomedical sciences, focusing on cancer, AIDS and emerging infectious diseases. The Biomedical Informatics and Data Science (BIDS) directorate works collaboratively and helps to fulfill the mission of Frederick National Laboratory in the areas of biomedical informatics and data science by developing and applying world leading data science and computing technologies to basic and applied biomedical research challenges, supporting critical operations, developing and delivering national data resources, and employing leading-edge software and data science to effectively enable and advance clinical trials. KEY ROLES/RESPONSIBILITIES Provide primary leadership of administrative functions and operations for BIDS program activities, tasks, and activities Serve as a key liaison between the office of the BIDS director and management, administrative, scientific and technical personnel both within and outside the program including working closely with government contract personnel and government staff Oversight of budget, project management and oversight of major program initiatives in a task order environment, which encompasses the coordination of cross-functional project teams and monitoring of the progress of implementation and adherence to required timelines, reporting requirements and deadlines Assess, implement and optimize business processes and workflows to ensure effective operation of the program and efficient utilization of resources Oversight of BIDS data tracking and information management applications and enhancing the functionality and integrity of these systems to meet contractual record keeping and reporting requirements Play an essential role in financial management activities including budget preparation, expense monitoring, analysis and reporting of budgetary performance Provides support of administrative functions that include review and coordination of Task Order documents, budget estimates, and associated changes Supervise and manage administrative and operations personnel supporting BIDS program, (effectively, manage PAO functions and personnel) Manage procurement functions, track facility maintenance/improvement costs, and oversee out-of-cycle requests BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in Business Administration (or similar degree). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to educational requirements, a minimum of eight (8) years of progressively responsible management/program administration experience related to government contracting environment General knowledge of financial management concepts and research facility operations Working knowledge of project management and information technology applications Experience should encompass budget analysis and data management Supervisory experience Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Master's degree Experience working in a task order contract environment Ability to independently identify and effectively resolve problems, to render decisions and policy interpretations Interact effectively with technical, scientific, supervisory, management and administrative personnel Strong organizational, project management, communication/presentation, technical writing skills and attention to detail Experience working in biomedical research environment or background in biological sciences, computational science, data science or related discipline Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 23, 2020
Full time
The mission of Enterprise Information Technology (EIT) is to develop an enterprise-level, consolidated information technology infrastructure that provides exceptional IT capabilities to the Frederick National Labs for Cancer Research (NCI-Frederick/FNLCR) in support of basic, translational, and clinical cancer and AIDS research. The IT Operations Group (ITOG) is a part of Enterprise Information Technology (EIT) within Leidos Biomedical Research, Inc. ITOG is responsible for computational servers, storage servers, virtual machine infrastructure, and the FNLCR network. ITOG focuses on implementing enterprise IT best practices in the areas of computational services, storage, backup, and archiving; batch and application support; server consolidation and virtualization; network infrastructure; unification of voice, teleconferencing, and video communication technologies; and improved infrastructure for collocation of dedicated servers. KEY ROLES/RESPONSIBILITIES The Information Technology Operations Group, part of Enterprise Information Technology, is responsible for information technology infrastructure, including high performance computing, enterprise storage and advanced telecommunications at the Frederick National Laboratory for Cancer Research. This position will provide technical support and solutions to the Frederick National Laboratory for Cancer Research centered on Linux based technologies in a VMware environment. The following tasks will need to be performed: Provide Linux system management and administration functions, including requirements analysis, systems configuration and performance monitoring Responsible for ensuring the availability, reliability, and security of Linux operating systems in a VMware environment as well as physical environment Install and maintain hardware, software, and applications Work with users to evaluate, troubleshoot and remedy needs and problems Implement proof of concept models for new technologies prior to release in to the production environment Monitor system performance and adjust as required Manage system monitoring servers and application (SolarWinds) and install/configure monitoring agents as necessary Participate in the integration of hardware and software, including vendors for support Adhere to configuration management principles across development, stage, and production environments Migrate and upgrade Linux systems nearing end of support BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for US equivalency In addition to the education requirements, a minimum of five (5) years of experience installing and maintaining CentOS and/or Ubuntu Linux Experience in monitoring system performance and availability Experience administering Apache web and tomcat servers Experience in installing and maintaining hardware, software, and applications Experienced in shell, perl, or python scripting Excellent problem management and troubleshooting skills and abilities to diagnose and resolve system related problems Understanding of IT systems best practices such as ITIL and the implementation of these practices, including the documentation and testing of systems Excellent communication and customer service skills Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with SolarWinds strongly considered Experience with configuration management systems such as puppet or foreman Medium level understanding of TCP/IP based networking MySQL, mariadb, MS SQL, or Oracle experience is a plus Medium level understanding of system and application security Moderate skills with Microsoft Office products EXPECTED COMPETENCIES Build new VMs using vSphere client Deploy new VMs from templates using vSphere Install and configure web services such as apache, Django, or tomcat Monitor system performance and make adjustments to hardware and/or software to mitigate problems Create, review, and update Standard Operating Procedures (SOP) and Service Level Agreements (SLA) Update patches of Linux operating systems Migrate and upgrade Linux systems nearing end of life Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 23, 2020
Full time
The Enterprise Systems group (BES) oversees the strategic vision and implementation plan for IT systems and solutions for the enterprise at Leidos Biomedical Research, the operational information and data systems support to Frederick National Laboratory for Cancer Research. KEY ROLES/RESPONSIBILITIES Business Enterprise Systems group is looking for a Cognos Developer. Our Enterprise Systems group is responsible for enabling the operational directorates across the NCI-Frederick with IT solutions and providing financial and operational reporting services and support across the organization. Specific roles and responsibilities could include: Design and enhance Cognos 11 Reports and Dashboards Work with data form multiple systems including Costpoint, Unanet, Maximo and others Work with dimensional data from Cognos TM1 and support TM1 standard and ad hock TM1 reports from existing TM1 applications and develop new TM1 capabilities Creating database ETL jobs for data transformations when required BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation in a related field. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U. S. equivalency In addition to the education requirements, a minimum of two (2) years of relevant experience is required Knowledge of Oracle and SQL Server Cognos 10/11 2+ years ANSI SQL 2+ years Relevant report development experience 2+ years Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with financial data and fields Experience with Costpoint Data Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 22, 2020
Full time
The Basic Science Program (BSP) pursues independent, multidisciplinary research programs in basic or applied molecular biology, immunology, retrovirology, cancer biology, or human genetics. Research efforts and support are an integral part of the Center for Cancer Research (CCR) at the Frederick National Laboratory for Cancer Research (FNLCR). This position is in the laboratory of Dr. Ruth Nussinov, a preeminent computational structural biologist and Senior Principal Investigator, leading her lab to novel, cutting edge research in the field. KEY ROLES/RESPONSIBILITIES A computationally strong candidate is required for an independent research project in the Nussinov lab at the Frederick National Laboratory for Cancer Research which involves the prediction and modeling of the interactions of microbiome proteins with those of the human host on a large scale. Additional Responsibilities: Handling large databases, High level programming proficiency, including machine learning, Statistical analysis, Familiarity with protein structures, Ability to interact closely with experimental groups to obtain molecular mechanisms The project aim to understand how microbiota can cause disease, particularly cancer BASIC QUALIFICATIONS Possession of a Doctorate degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a biomedical related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. No experience required beyond the educational requirement Published first-authorship papers in international journals, in English, and the ability to write papers Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Knowledge of the microbiome and experience in working on microbiome projects Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 22, 2020
Full time
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 Provide chemistry support to the FNL/NCI RAS Initiative and work closely with a highly collaborative multidisciplinary team of chemists, biochemists, structural biologists, and cell biologists to develop and optimize pharmaceutical agents for use as RAS inhibitors Design and synthesize pharmaceutically relevant small molecules for targets implicated in cancer Synthesis of covalent fragments to supplement our fragment screening library Conduct hit-to-lead chemistry efforts around targets identified as advanceable hits Stay informed of the latest findings in cancer drug discover and organic synthesis BASIC QUALIFICATIONS Possession of a doctorate degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency No experience is required with the Doctorate degree Strong background in organic synthesis and/or medicinal chemistry Expertise in the design, synthesis, and characterization of pharmaceutically relevant small molecules Familiarity with modern analytical technologies including: LCMS, NMR (1H, 13C, 2D techniques), HPLC, Flash chromatography, IR spectroscopy Must be highly collaborative, self-motivated, and team-oriented Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS 2 years of experience (post-PhD) in medicinal chemistry Experience of fragment-based drug discovery Knowledge of cancer drug discovery Familiarity with common screening platforms used in cancer drug discovery EXPECTED COMPETENCIES Able to balance workload over multiple projects Excellent communication skills Works well within a multidisciplinary team of Chemists, Biologists, and Computational Chemists JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 22, 2020
Full time
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 Sequencing Facility is a high throughput laboratory providing cutting edge next generation technologies to the National Cancer Institute. The candidate will be responsible for: Assisting with next generation (NGS) sequencing for the core facility Current platforms include the Illumina NovaSeq, NextSeq, MiSeq, iSeq, PacBio, and additional platforms in the future All projects are of a highly specialized nature and require technical proficiency, problem solving skills and good judgment Responsible for all ongoing daily activities including library prep and sequencer set up, maintenance of equipment, use of protocols, sample quality control and troubleshooting of problems with direct coordination of the supervisor Requires adherence to strict safety protocols and may require the use of personal protective equipment BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for US equivalency In addition to the education requirements, a minimum of five (5) years of related experience in molecular biology Experience with production of NGS libraries, sample and library quality control, and sequencing machine set up is essential Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Proficiency utilizing onboard sequencer and commercial bioinformatics tools, core or service facility experience and the ability to assist in new protocol development Experience with multiple next generation sequencing technologies including Illumina NextSeq or NovaSeq Working knowledge of DNA hybridization, ligation, fragmentation, end polishing, PCR, automation using robotics, Agilent Bioanalyzer, nanodrop, qPCR, sterile/clean room techniques, and sample and process tracking through LIMS The ideal candidate must have the ability to organize and utilize reagents and samples for high-throughput analysis in support of genomic studies and two years proven experience in DNA sequencing, data review and stringent record keeping 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)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 21, 2020
Full time
The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide. KEY ROLES/RESPONSIBILITIES Reporting to the cGMP Cleaning Supervisor, the cGMP Cleaning Technician will: Work each day from 4:00 am to 12:30 pm Be responsible for cleaning throughout the facility to include clean rooms, laboratories, restrooms, warehouse and other areas as needed in order to maintain and conform to FDA and cGMP guidelines and regulations for cleaning practices - cGMP training and training on specialized equipment will be provided Maintain clean room environment below alert limits by following established cleaning practices Clean and wash walls, ceilings, windows (inside and outside) and screens, equipment exteriors, carts, tables, chairs, stools, benches, door handles, door push plates, door latch releases, light switches, telephones, floors, and locker rooms following established aseptic techniques and using appropriate solutions Be responsible for preparation of solutions, solution disposal, trash disposal and water collection Clean administrative and laboratory areas, including vacuuming rugs and removing stains and foreign matter from a variety of surfaces using proper cleaners Move office furniture and equipment for cleaning Sweep, mop, strip, scrub, wax, and polish floors using industrial power equipment Wash and clean windows and ceiling air vents Dust and clean office areas, woodwork, furniture, floor coverings, fixtures, stairwells, fire doors, and empty trash containers Dispose of biological waste materials Clean and disinfect rest rooms, replenish paper supplies, and Provide general cleanup outside of buildings. BASIC QUALIFICATIONS Requires an 8th grade education or higher Foreign degrees must be evaluated for U.S. equivalency Ability to work in a BL2 lab Ability to pass aseptic gowning validation Ability to work in environment with potential exposure to particulates, vapors or noise and ability to wear a full-face respirator Ability to operate industrial power equipment used for cleaning Ability to perform physical duties including: Lifting and carrying up to 50 lbs. Walking, standing, climbing stairs, bending, stooping, and working in confined areas Ability to read and understand written instructions and follow SOPs Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with cGMP guidelines and regulations for cleaning practices Knowledge of proper waxes, strippers, polishes, and stain removers required to clean assigned areas JOB HAZARDS This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 19, 2020
Full time
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. PROGRAM DESCRIPTION We are looking for an experienced and creative individual to join our team. As a Digital Media Specialist, you will be responsible for developing and implementing FNL's web and social media strategy and growing our online presence to support the organization's operational goals. KEY ROLES/RESPONSIBILITIES Establish, implement and manage digital media strategies using all available tools (e.g. website, social media platforms) Partner with scientists, technicians, physicians, business administrators, human resources staff, business development and procurement professionals, and others across the organization to ensure alignment with company objectives and plans Create and update website content on a regular basis, while also managing long-term development projects to support the organization's priorities Continue to develop a network of content providers across the organization to ensure that website content remains current Support and protect the organization's branding Define most important digital media KPIs Manage and oversee website and social media content, including images, video and text Create editorial calendar for all digital media platforms and execute conversations daily Develop engagement growth strategy for all platforms Measure the success of social media campaigns Stay current with latest digital media best practices and emerging technologies and digital platforms Use digital media marketing tools such as Buffer Track and analyze SEO in order to provide effective solutions for content optimization Analyze web traffic metrics and suggest solutions to boost web presence Optimize online content and tactical activity to continually grow organic earned search Establish relationships with peers at relevant government agencies and other national laboratories to build synergy among social media assets Serve as in-house digital media expert; counsel and assist laboratory leadership and staff to build and enhance opportunities for personal digital presence BASIC QUALIFICATIONS BA or BS in related field. All degrees must be evaluated for U.S. equivalency A minimum of two (2) years of related experience Strong copy writing, copy editing, and proofing skills Solid understanding and implementation of SEO Familiarity with web content management systems Familiarity with commonly used style guides Basic design and multimedia skills Must be able to observe business situations, recognize opportunities and recommend solutions Must be able to adapt to changing priorities while consistently meeting deadlines with accuracy Must be able to obtain and maintain a security clearance. PREFERRED QUALIFICATIONS Experience working within a scientific environment Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 17, 2020
Full time
The AIDS and Cancer Virus Program (ACVP) is an integrated, multidisciplinary program that pursues basic and applied studies aimed at improving our understanding of AIDS-associated viruses and disease, including studies intended to facilitate the improved diagnosis, prevention and treatment of HIV infection and AIDS. The Program consists of five independent but highly interactive research Sections headed by Principal Investigators, whose work spans from fundamental molecular virology through in vitro studies, to in vivo studies in non-human primate (NHP) models. The ACVP also has eight Research Support Core Groups (Cores) that provide critical and often unique technical support capabilities to ACVP laboratories and other laboratories within the NCI and NIH, and to extramural investigators. KEY ROLES/RESPONSIBILITIES The Bioinformatics Analyst is responsible for providing bioinformatics and data analysis support to the investigators at the AIDS and Cancer Virus Program (ACVP). The successful candidate will be responsible for: The analysis and interpretation of complex biological data sets (e.g. next generation sequence data, time series data, flow cytometry data, and microscopy images) Adapting existing bioinformatics tools and designing and developing custom analyses to address the unique and diverse needs of different investigators Mining and synthesizing existing and new biological data sets to generate novel hypotheses or insights Presenting analysis results, in a clear and concise manner, to an audience not familiar with bioinformatics Helping to maintain the existing File Maker Pro database with underlying ORACLE data storage The Bioinformatics Analyst will have the opportunity to work directly with several principal investigators within the program who have broad research interests. Additionally, the candidate will be able to interact directly with both an internal small group of dedicated computational scientists and with a large computational department at the Frederick National Lab. This position allows for both independent and collaborative research. BASIC QUALIFICATIONS Bioinformatics Analyst III Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency Minimum of five (5) years of progressively responsible relevant experience as designated by the program requirements Bioinformatics Analyst II Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency Minimum of two (2) years of progressively responsible relevant experience as designated by the program requirement Bioinformatics Analyst I Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency No experience required with a Bachelor's degree PREFERRED QUALIFICATIONS A Masters' Degree in any quantitative science is preferred Commitment to solving biological problems Ability to multi-task across projects Record of scientific achievements including journal publications or poster presentations Previous experience working directly with principal investigators or in a wet lab Interest in working across a wide range of rapidly changing and divergent research interests Proficient written and oral communication skills EXPECTED COMPETENCIES Deep understanding of and some experience in processing large biological data sets: data cleaning, normalization, analysis, interpretation and visualization Ability to understand and analyze data from complex experimental designs Familiarity with standard bioinformatics analyses for next generation sequencing data (quality control, sequence alignments, variant calling) Proficiency in R and some experience with Python An adequate understanding of database management
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 17, 2020
Full time
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. The Center for Molecular Microscopy (CMM) main purpose is to provide access to Electron Microscopy Techniques using state-of-the-art equipment to the intramural cancer research community focusing on collaborating with CCR/NCI Investigators. KEY ROLES/RESPONSIBILITIES In contributing to the CMM mission, the successful candidate will develop and maintain the CMM's data collection pipeline, data quality control measures and data processing. Specifically, the data analysis specialist will perform the following: Perform single particle cryo EM data analysis to obtain 3D volumes using Relion, cryosparc and other related software Perform cryo-tomography data analysis using imod and other related software Develop and assemble workflows for high-throughput transfer and quality control of cryo-EM images Coordinate CMM infrastructure needs with IT support department Maintain and support server storage and work with IT support on any potential issues Develop and maintain more efficient workflows, feedback, and progress reports on projects Provide technical advice to investigators on data analysis and processing BASIC QUALIFICATIONS Possession of a Doctorate degree from an accredited college or university according to the Council for Higher Education Accreditation in Biological Sciences, Structural Biology, or related discipline. Foreign degrees must be evaluated for U.S. equivalency No work experience required with a Doctorate degree EM as well as cryo-tomography data processing experience is required Experience preparing detailed, concise reports Good verbal and written communication skills Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with single particle cryo Experience with micro-ED data processing Experience with command line Linux environment and Linux scripting Experience in data management and data analytics Experience in running analytical data reports Experience with electron microscopy Experience with programming in Phyton Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 16, 2020
Full time
Program Description : The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) ad 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 of how we do our work everyday in serving the public's interest. Frederick National Laboratory Ethics and Compliance Office provides centralized leadership and operational capabilities in areas such as ethics, internal and external auditing, corporate and operational compliance as well as business process functions. The Manager of Internal Audit is responsible for continuous improvement of the enterprise-wide Internal Audit program to assist management in ensuring adherence to company policies, and regulatory requirements while using audit standards. The Manager of Internal Audit serves as a mentor to team of internal auditors and a leader in the Compliance organization as well as a trusted business partner to internal stakeholders. The position reports to the Chief Ethics and Compliance Officer and works across the Operations, Scientific, and Clinical Groups in a collaborative, accountable, and results driven manner. Key Roles/Responsibilities: Manager of Internal Audit Responsible for managing the internal audit program and developing and executing an audit plan to ensure continuous improvement. Plans, organizes, directs, staffs, and controls the auditing of the accounting and financial data of all departments within the organization. Cultivate trust based working relationships with key internal stakeholders to support the department and business objectives. Conducts performance, operational, compliance and financial audits of company programs. Responsible for evaluation and selection of staff, planning and coordination of training, assigning tasks, scheduling workloads and evaluating employee performance. Directs the review and verification of records, compliance with standards and policies and procedures. Test and evaluate internal control structures and make recommendations for improvement. Oversees and presents audit findings, data/trend anaylysis and recommendations to senior and executive management. Manages a tracking system to follow up on all findings of internal and external audits. Provides technical assistance to entities being audited and other interested parties regarding the company audit program and procedural matters. Interact with senior leadership regarding alignment of operational performance and business objectives. Basic Qualifications: To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a BS/BA degree in a related discipline from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency, Eight (8) years of industry demonstrated experience in two or more of the following areas- internal audit, finance/accounting, project management with at least 3 years in a supervisory capacity. Working knowledge of Accounting and Auditing principles, procedures and techniques to include: Generally Accepted Accounting Principles (GAAP); Defense Contract Audit Agency (DCAA); Federal Acquisition Regulations (FAR), Federal Travel Regulations (FTR) and Cost Accounting Standards (CAS). Preferred: Candidates with these desired skills will be given preferential consideration: Master's degree in a related field CPA license Professional accreditations such as Certified Internal Auditor (CIA) or similar
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 16, 2020
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program Directorate (CMRPD) provides regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the Regulatory Compliance and Human Subjects Protection Program (RCHSPP), Office of Clinical Research Policy and Regulatory Operations (OCRPRO) of the National Institute of Allergy and Infectious Diseases' (NIAID) Division of Clinical Research (DCR). KEY ROLES/RESPONSIBILITIES Provides clinical trials monitoring for Phase I-III single site to large networks of clinical sites participating in Investigational New Drug (IND) and non-IND protocols Ensures sites are following U.S. Food and Drug Administration (FDA) regulations for INDs, Investigational Device Exemptions (IDEs), International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) guidelines, and other applicable regulations Verifies source documentation for the appropriate recording and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) Critically evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plans Provides monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution, accountability and the processing and disposal of returned investigational agents according to the study monitoring plans, protocol and Standard Operating Procedures (SOPs), chain of accountability. Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and field CRAs Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture Reviews protocol and Informed Consent Forms (ICFs) and provides assistance to the clinical investigators Coordinates monitoring activities of clinical studies for domestic and international sites including: conducting site initiation, monitoring and close-out visits, completing reports in a timely manner, ensuring the conduct of the trial is in compliance with the approved protocol, SOPs, International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), Institutional Review Board (IRB)s and NIH policies, and applicable regulatory requirements Assists other CRAs and Project Managers in the development of team processes and study-related documents Assists with ensuring required approvals are in place to initiate intramural research Assists in the preparation and production of documents for FDA submissions, as well as IND annual protocol reports and manuscripts Reviews or helps create internal and/or external SOPs, guidelines and tools Travels to domestic and possible international clinical sites as assigned Maintains Essential Documentation File contents and reconciliation of the documentation including ensuring all required essential study documents are current, complete and accurate Ensures Clinical Trial Database Systems are updated to be current, accurate and complete in a timely manner This position is located in Frederick, Maryland BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research, clinical trials and/or health or four (4) years related experience in lieu of degree Foreign degrees must be evaluated for U.S. equivalency A minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent clinical trials Ability to work in a clinical research setting, both independently and within a team Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines Ability to communicate effectively, verbally and in writing, as well as give presentations with non-technical and technical staff General knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and GCPs Knowledge of TrackWise®, or other Clinical Trials Management Systems (similar systems such as OpenClinica, ClinPlus, etc.) Extensive experience using various software applications such as MS Excel, Word, PowerPoint, and Adobe Acrobat; relational database structures and reporting software Ability to manage projects involving large volumes of data Must be willing to travel approximately 30-40 % (including to NIH) Previous clinical monitoring or site management experience Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Infectious diseases experience Knowledge of Department of Health and Human Service (DHHS) regulations is a plus Experience with the development of manual of operations and study monitoring plans Knowledge of conducting federally funded studies Ability to read French or Spanish ACRP Certified CRA or SOCRA Certified Clinical Research Professional Knowledge of international regulatory requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Rockville, MD, USA
Jan 16, 2020
Full time
The Frederick National Laboratory is dedicated to improving human health through the discovery and innovation in the biomedical sciences, focusing on cancer, AIDS and emerging infectious diseases. The Biomedical Informatics and Data Science (BIDS) directorate works collaboratively and helps to fulfill the mission of the Frederick National Laboratory in the areas of biomedical informatics and data science by developing and applying world leading data science and computing technologies to basic and applied biomedical research challenges, supporting critical operations, developing and delivering national data resources, and employing leading-edge software and data science to effectively enable and advance clinical trials. The Biomedical Applications Development Center (BADC) is part of BIDS and is primarily involved in developing the informatics system and providing data reporting capabilities for precision medicine clinical trials supported by NCI. BADC designs, develops, operates and maintains the artificial intelligence systems associated with the assignment of patients to treatment arms. BADC is a diverse team of computer scientists, bioinformaticians, and managers who work together using Kanban/Agile principles and serverless computing in all their efforts. Using leading edge cloud systems, BADC has been recognized for their innovative work in Cancer research. KEY ROLES/RESPONSIBILITIES Lead a team of engineers to design, develop, and test software engineering solutions for the Clinical Trials Reporting Program (CTRP) Work with the program management team to prioritize feature development and release Provide end users with engineering support in a timely manner Recruit, mentor, and manage an effective software engineering team BASIC QUALIFICATIONS Possession of a Master's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U. S. equivalency In addition to the education requirements, a minimum of four (4) years of experience in developing enterprise software in a fast-paced, agile development environment Programming experience with modern web technologies such as Java, Python, React/VueJS, SQL/NoSQL in the AWS Cloud environment Experience developing distributed system and have a good understanding of event-based and microservice architectures The ability to keep a project on track and remove roadblocks for the engineers Actively adopt, contribute, and advance practices and norms that achieve well design system and maintainable code Possess good oral and written communication skills. Demonstrate the ability to present complex ideas to teams and management that is easy to understand Enjoy learning and collaborating with diverse team members and a strong desire to coach junior team members Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS (_1-2+_) years of experience managing a team of 3-5 software engineers and can lead a technical analysis and design, evaluate trade offs, and follow industry best practices Experience with Java, JEE, RDMS Experience with Amazon Web Services such as Lambda, S3, SQS, SNS, and Step Functions Experience with the Python programming language Experience with Docker and related technologies Experience with SQL/NoSQL databases such as Postgres, Redis, DynamoDB, ElasticSearch Experience in genomics, clinical trial research and/or precision medicine Experience with agile software development such as Kanban and SCRUM Experience with Test-Driven and Behavioral-Driven Development Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Jan 16, 2020
Full time
The Clinical Monitoring Research Program Directorate (CMRPD) is assisting the National Heart, Lung, and Blood Institute (NHLBI) to develop and implement a well-defined Program Management and Support Services (PMSS) framework and infrastructure that can quickly integrate project/program management and other support functions under a matrixed team concept, committing personnel and expertise from multiple organizations within the Institute. This PMSS will directly support major NHLBI initiatives and will allow for implementing robust project management processes and procedures across the Institute through training efforts, policy development, change management strategies, and other means as may be necessary. The NHLBI provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide. KEY ROLES/RESPONSIBILITIES Lead the planning and establishment of the PMSS and underlying program management infrastructure at the NHLBI by leveraging and developing policy, SOPs, tools, templates, and trainings Develop and recommend to NHLBI a robust Concept of Operations (CONOPS) plan for the PMSS that will be established organizationally under the technical direction of the NHLBI Office of the Executive Officer Identify initiative support requirements and establish matrixed program management support teams, with clear roles and responsibilities, that draw upon a diverse set of skills and capabilities from distinct organizations within the Institute and from external organizations Develop and maintain a unified monitoring and reporting framework across initiatives, such that cost, schedule, interdependencies, performance, and risk can be effectively managed at the initiative level and easily up channeled for Institute leadership input when appropriate Develop and maintain reporting framework that provides sufficient information for senior leadership to identify, integrate, and align synergistic activities of these initiatives as they evolve in a dynamic environment Develop and maintain tools, systems, documentation, standard templates, and other artifacts needed to accomplish the objectives of the PMSS, and to build out a robust infrastructure for the PMSS Implement robust project management practices and thinking among NHLBI staff through policy development, change management strategies, targeted training efforts, and other means as may be necessary subject to the approval of the NHLBI Provide recruiting support for candidates that meet unique blends of scientific and project management skill sets This position is located at NIH/NHLBI, Office of the Executive Offices, Building 31, Suite 5A48, 31 Center Drive, Bethesda, Maryland, 20892 BASIC QUALIFICATIONS Master's degree in Science, Business Management or related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency In addition to educational requirements, a minimum of eight (8) years of operations management/program administration experience Minimum of five (5) years experience in a clinical management and/or a leadership role in a life sciences, pharmaceutical or biotechnology environment Experience leading and providing senior level program/project management for complex business including the integration of comprehensive activities Ability to independently manage and prioritize multiple complex projects at a director level Ability to effectively lead, manage, organize and interact with other members of senior management Ability to apply leadership and interpersonal skills by use of strategic thinking, team and project leadership, staff development and decision-making Ability to excel in fluid working environments and adapt to changing priorities Ability to adapt and perform under innovative business, project and funding mechanisms Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS PhD degree Project Management Certification Experience creating/managing a culture of change from one with very limited project management to one with well-defined processes/procedures Demonstrated experience managing portfolios with many complex projects/programs; special interest in experience involving early translational, pre-clinical, and/or clinical research-related projects Familiarity and experience with federal government programs Ability to clearly communicate and collaborate across divisions and programs and with numerous external stakeholders Ability to attend meetings as a program liaison Ability to create and maintain business processes and write, interpret and implement various policies and procedures, ensuring smooth operations Detail-oriented with a proactive approach Proficiency with Microsoft software applications Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 15, 2020
Full time
The Financial Operations Directorate (FOD) is committed to ensuring the financial integrity of the Frederick National Laboratory for Cancer Research (FNLCR) by providing timely, accurate, and relevant information to internal and external stakeholders. Our team collaborates to effectively monitor and manage fiscal resources in a responsible, compliant, and professional manner in a dynamic environment. We adhere to applicable contract, regulatory, and compliance requirements while supporting the broader mission of the FNLCR. KEY ROLES/RESPONSIBILITIES Leidos Biomedical Research, Inc is seeking an Accountant II who will be responsible for completing daily, monthly, and year-end tasks for a government customer. Which includes, but is not limited to: Build and maintain cross-functional team relationships with Project Management/Control, Contracts, Accounts Payable to provide expertise and assistance on invoicing matters in a fast-pace environment Complete reconciliations of balance sheet accounts Research accounting transactions related to GL, AP and AR Prepare journal entries Prepare financial reports and analysis of data Process cash disbursements Handle special accounting projects or inquiries BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university in field related to accounting or four (4) years related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency A minimum of three (3) years of general accounting with responsibility for general ledger, billing, accounts payable, cost accounting, or accounts receivable Experience with Costpoint Excellent verbal, interpersonal, and written communication skills Strong analytical and problem-solving capabilities Must be deadline driven, fast paced, organized and detail oriented Knowledge of accounting principles and practices Microsoft office software with intermediate MS Excel Time Management - Implements work activities in accordance with priorities and schedules Customer service oriented with a positive attitude Ability to work in a team environment Ability to learn new technology Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Knowledge of GAAP, FAR, FTR, CAS Deltek Costpoint software experience Experience working in Cognos Previous government accounting experience
Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Jan 15, 2020
Full time
PROGRAM DESCRIPTION Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program Directorate (CMRPD) provides implementation and oversight of multiple NCI/CCR cell processing facilities within the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch Cell Production Facility. KEY ROLES/RESPONSIBILITIES Assists with preparation of technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance Assists with development and implementation of procedures/programs to ensure effective and efficient business and operational processes Helps to identify potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them Assists with coordination of logistics, including purchasing and shipping of miscellaneous equipment, lab and office supplies to ensure compliance with appropriate government regulations Maintains workflow and follows timelines to ensure production operations are on schedule and adequate raw materials and supplies are available Assists with technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control Tracks EM samples (testing, results, actions) Follows PM schedule and reporting The position is located in Bethesda, Maryland BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research/scientific discipline or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency No experience is required with a Bachelor's degree (relevant experience may be substituted for the degree) Knowledge of production-related principles of biopharmaceutical development and production processes Knowledge of cGMPs as they relate to biopharmaceutical manufacturing Use of aseptic/sterile techniques Self-motivated and willing to accept/learn temporary responsibilities outside of the initial job description Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Knowledge of handling and propagation of human primary cells, including T cells Ability to strictly adhere to SOPs and cGMP regulations Rxcellent documentation skills Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) JOB HAZARDS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Jan 15, 2020
Full time
About the Frederick National Laboratory for Cancer Research (FNLCR) The Frederick National Laboratory for Cancer Research is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and currently operated by Leidos Biomedical Research, Inc. The laboratory 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 disease. Our scientists conduct basic, hypothesis-driven research and collaborative studies that span a wide range, including genetics, genomics, protein science, proteomics, bioinformatics, high-performance biomedical computing, laboratory animal sciences, and clinical operations. The FNLCR provides rapid response to emerging health threats, mobilizing effective resources to address disease outbreaks and investigate newly recognized pathogens. We also monitor more than 400 ongoing human clinical trials in the United States and overseas. The laboratory is accelerating progress in the fight against cancer, AIDS, and other infectious diseases; stimulating research collaborations; and creating opportunities for technology transfer and business and economic development. These activities represent the necessary investment to maximize the benefits of scientific discovery and innovation on human health. Enterprise Information Technology (EIT) Program Description The mission of Enterprise Information Technology (EIT) is to develop an enterprise-level, consolidated information technology infrastructure that provides exceptional IT capabilities to the Frederick National Labs for Cancer Research (NCI-Frederick/FNLCR) in support of basic, translational, and clinical cancer and AIDS research. The High-Performance Computing (HPC) team is a part of Enterprise Information Technology (EIT) within Leidos Biomedical Research, Inc. The HPC team is responsible for technical operation, support and continued development of the first class HPC facilities of FNLCR in order to enhance the productivity of the scientific staff and research colleagues of the labs. Key Roles and Responsibilities The HPC Systems Administrator's primary objective will be to build, operate, monitor, maintain, secure, and develop FNLCR HPC systems and software for scientists and researchers. You will assist science and research groups in taking full advantage of Frederick Research Compute Environment (FRCE) installed at FNLCR. You will work closely with the scientific groups to develop a long-term strategy and relationship between the HPC team and the scientists, with a focus on maximizing efficient utilization of the FRCE environment, helping ensure scientists and researchers needs are met, and developing new and novel solutions to support the science. The candidate will be responsible for the following: Elevating the customer experience by providing proactive and customer-centric service Installing, configuring, and maintaining a large compute environment based on modern HPC nodes, CPU and GPU, along with associated batch control and application software Day-to-day operations of the systems including systems administration, monitoring and storage performance up to and including network components. Management of the system's file system, HPC software stack and tools. Maintenance and configuration of the SLURM scheduling and queuing system. Collaboration with scientists and researchers to assure appropriate software/environment builds are accessible to the users and functioning efficiently Diagnosing and resolving system operational problems quickly and effectively. Coordinating with vendors to resolve hardware and software problems. Assist users with access and other help desk ticket requests or issues. Use scripting/programming skills to enable system-level automation, problem detection, security maintenance and patch management. Building and deploying open source software and software from vendors/partners. Documenting system administration procedures for routine and complex tasks. Maintaining and monitoring the security of the HPC systems and servers. Other duties as assigned. BASIC QUALIFICATIONS Level III Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation.(Additional qualifying experience may be substituted for the required education).Foreign degrees must be evaluated for US equivalency In addition to the education requirements, a minimum of five (5) years of experience installing and maintaining CentOS Linux Experience administering Apache web and tomcat servers Experience in installing and maintaining physical servers Experience in installing and maintaining hardware, software, and applications Experienced with shell, perl, or python scripting Assists in batch infrastructure configuration and daily operations Level IV Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation.(Additional qualifying experience may be substituted for the required education).Foreign degrees must be evaluated for US equivalency In additional to the education requirements, a minimum of eight (8) years of experience installing and maintaining CentOS Linux Experience administering Apache web and tomcat servers Experience with puppet/satellite/foreman configuration managers Proficient with shell, perl, or python scripting Proficient in one or more compiled languages (C, Fortran, C++) Technical experience in compiling, installing, and testing open-source scientific applications Excellent problem management and troubleshooting skills and abilities to diagnose and resolve system related problems Develops and maintains detailed and accurate documentation of Linux and application related procedures Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)