Frederick National Laboratory for Cancer Research

Frederick National Laboratory for Cancer Research Frederick, MD, USA
Nov 16, 2019
Full time
The Environmental Health and Safety Program is responsible for environmental protection, occupational safety and health, protective services, and emergency preparedness programs at the National Cancer Institute at Frederick. KEY ROLES/RESPONSIBILITIES Performs safety and environmental compliance tasks and provides assistance and other services as needed; employee instruction on safety and health and pollution prevention, inspection/delivery of isotopes, packaging of hazardous material for pickup, hazardous spill cleanups, hazard decontamination, hazardous waste disposal, etc. Attends training sessions to obtain appropriate certifications from MDE, EPA, DOT, etc. Identifies and monitors safety/health hazards, exposures, and environmental concerns and initiates corrective action. Performs workplace safety inspections, reports results, and monitors corrective actions. Conducts surveys for evidence of contamination by radioactive, chemical, or biological hazardous materials. Instructs NCI at Frederick personnel in use of safety equipment and instrumentation. Maintains and calibrates EHS instrumentation. Conducts surveys and inspections of work areas to assess safe work conditions. Maintains effective communications with a broad range of employees. Serves on task forces, planning teams and relevant committees. As determined by the program requirements, this position may be designated as a Primary Driver and will be responsible for complying with the Leidos Biomedical Use of Government Owned or Leased Vehicles Policy. Learn and apply a variety of procedures used in safety and environmental control operations: operate and maintain specialized equipment and instrumentation; deliver work of high quality; produce effective written and oral communications; use pertinent computer software. Position requires a strong service orientation toward the Frederick National Lab for Cancer Research community where all duties are conducted in a collegial manner. Maintain confidentiality pertaining to occupational exposure, medical and similar data. Successful completion of college level general coursework in algebra physics, biology and chemistry; demonstrated knowledge of standard scientific methods and measuring instruments. Familiarity with safety regulations to include OSHA, DOT, MDE, EPA, NRC, etc. BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (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 Experience in safety operations, preferably at a biomedical research facility or an institution of higher education, may be substituted for the degree Must be able to obtain and maintain a security clearance JOB HAZARDS OR REQUIREMENTS Candidate will be entering an animal facility or have the potential for exposure to animal allergens 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 Candidate is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance Candidate is subject to the following environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job. Candidate would be working with radioactive materials and requires them to become an approved radiation worker 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
Nov 16, 2019
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 Perform antibody screening using immunohistochemistry (IHC) and other molecular biology techniques following SOPs Design, test and write detailed technical SOPs for antibody characterization assays (immunoassays) Analyze, interpret and effectively present data to team member and collaborators 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 U.S. equivalency In addition to the education requirements, a minimum of two (2) years of experience is required Highly collaborative, self-motivated, and team-oriented Excellent communication skills Familiarity with immunoassays (e.g. ELISA and Western Blot) Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with immunohistochemistry Experience with general molecular biology techniques Familiarity with graphic editor software such as Adobe Photoshop 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
Nov 16, 2019
Full time
Leidos Biomedical's 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. KEY ROLES/RESPONSIBILITIES The Auditor II performs internal assessments of various departments within Leidos Biomed to include reviews of purchasing, payroll, finance, travel, invoice review, and research subcontracts. Audits for procedural, statutory, program compliance or operational effectiveness. Inspects payroll records, assets, liabilities, inventories, disbursements, canceled checks, etc. to ascertain validity of information to determine dependability of record keeping and reporting practices Review travel for compliance with Federal Travel Regulations (FTR) Ability to write and establish new audit procedures and processes and train and develop lower level auditor staff on new procedure. Candidate must be detailed oriented and proficient at communication at all levels of the organization Assist in the development of the annual audit program Provides technical assistance to entities being audited and other interested parties regarding the company internal audit and compliance programs Knowledge of: Accounting and auditing principles, Federal Acquisition Regulations (FAR), Federal Travel Regulations (FTR), and Cost Accounting Standards (CAS) Awareness of Defense Contract Audit Agency (DCAA) procedures, FAR part 31 - allowable costs. Will be performing pre-award audit of 3rd party subcontractors Review consulting agreements for compliance with internal policies and procedures and IRS rules Review remediation of prior audit findings in Purchasing, Accounting and other areas of the organization related to both internal and external audits Audit of task order close out and communicating results for forward pricing practices Quarterly review of documentation to support allowable costs to the subcontract Review of P-card transactions for compliance with documentation requirements allowability per Purchasing Policy. Developing new audit procedures and implementing new internal controls Ability to document internal controls and work with process owners for process improvement Other duties as assigned by the Manager of Compliance, Control & Audit BASIC QUALIFICATIONS Possession of Bachelor's degree in Accounting or related field from an accredited college/ 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 education requirements, a minimum of five (5) years of auditing experience is required Ability to understand a process, document control environment, and provide recommendations for improvement Ability to audit new areas of the organization, create new audit and compliance programs Able to apply special governmental rules and regulations about accounting and auditing practices Knowledge of accounting and auditing principles and practices Able to work independently with minimal instructions on new audits and write audit procedures for other auditors to follow Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Certified Internal Auditor (CIA) not required but preferred Master's Degree in business or related field, not required but preferred Possess significant personal initiative and tenacity both when working alone or as a member of a team Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research United States
Nov 16, 2019
Full time
The Clinical Pharmacodynamic 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 (NCI). 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. PADIS facilitates mechanistic and performance analysis of putative anti-cancer agents, and therapeutic interventions to clinical applications, 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. KEY ROLES/RESPONSIBILITIES Development, validation and implementation of multiplex immunofluorescence clinical pharmacodynamic assays on fixed tissue Design, perform and analyze in vitro experiments to test pharmacodynamic marker responses to novel anti-cancer therapeutics in multiple formats, but particularly in multiplex immunofluorescence analysis of tissue-based assays Generate materials and data necessary to support the primary experimental objectives of the program Support development and implementation of multiplex immunofluorescence assays in support of clinical studies and initiatives Design experiments and strategies to test and confirm putative mechanism of action of clinical trial candidate compounds Perform imaging and analysis of marker expression in tissue (xenograft, PDX and human) using advanced instrumentation and imaging software Application of validated PD biomarker assays to analysis of preclinical models and human specimens to understand mechanisms of action and therapeutic responses Develop and optimize Standard Operating Procedures (SOPs) for clinical assays using imaging and analysis approaches and train others to facilitate assay transfer Data analysis and reporting of results from clinical specimen biopsies to the NCI Manage multiple projects, design and perform experiments hands-on, interpret data and present results to the program leadership and to the NCI BASIC QUALIFICATIONS Possession of a Doctoral degree from an accredited university degree according to the Council for Higher Education Accreditation (CHEA) 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 education requirements, a minimum of two (2) years of competent, innovative research experience beyond doctoral training is required Demonstration of specific training in cancer biology or DNA repair is required Experience in the design and validation of multiplexed immunofluorescence assays and the ability to work across testing platforms during the assay development process Experience with quantitative image analysis software (Definiens) Experience with fluorescence widefield and confocal microscopy Identification and validation of novel biomarkers Design and implementation of cell-based assays to test mechanism of action of candidate compounds Ability to master novel technologies and instrumentation in response to changes in project priorities or breakthrough technological innovations; hands-on instrumentation work is required for this position Ability to independently develop, modify methods and techniques Experience in elucidating mechanism of action of DNA damaging agents and drugs targeted to DNA repair, cell cycle control and apoptosis Ability to communicate with program lead researchers in a demanding scientific environment through preparation of formal reports Ability to maintain precise records Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Demonstration of experience in elucidating mechanism of action of DNA damaging agents and drugs targeted to DNA repair, cell cycle control and apoptosis A record of publication in the refereed scientific literature JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) 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 Candidate is subject to the following 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)
Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Nov 15, 2019
Full time
The Clinical Monitoring Research Program Directorate (CMRPD) is assisting 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. NHLBI anticipates that the PMSS will manage multiple Large-Scale Complex Initiatives that will involve program management coordination and support of personnel from organizations across the NHLBI, multi-tiered governance structures, national level stakeholders, and multiple awardees that are performing work as a consortium under Other Transaction Agreements. Although precise needs of each initiative will vary, the Key Roles/Responsibilities of the NHLBI Cure Sickle Cell Initiative provides a sense of the scope of work involved with these kinds of initiatives. KEY ROLES/RESPONSIBILITIES Facilitate communications and engagement of researchers and other related stakeholders in the early translational sciences of heart, lung, and blood research including novel therapies for diseases and cross-cutting early translational research, among others Management of a consortium of awardees related to pre-clinical studies, translational, clinical, implementation and data science; economic research; and enabling tools and technology Develop/Support public-private partnerships and collaborations among government agencies, private sector entities, researchers, and others to result in more rapid advancement of new and innovative treatments and technologies This position is located at NIH/NHLBI, Office of the Executive Offices, Building 31, Suite 5A48 (or similar location), 31 Center Drive, Bethesda, Maryland, 20892 BASIC QUALIFICATIONS Possession of a Ph.D. degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency. In addition to educational requirements, a minimum of 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 Demonstrated ability to lead scientific research projects or clinical trials by overseeing and integrating all aspects of the effort, setting deadlines, assigning responsibilities, monitoring and summarizing progress of project and program Must be detail-oriented, creative and flexible Strong organizational skills and the ability to prioritize multiple tasks and projects Exceptional written and oral communication skills Previous experience directly managing multiple concurrent research projects Experience related to clinical operations (e.g., development of Standard Operating Procedures (SOPs), staff development and training, resourcing/staffing, and budget planning and execution) Experience with scientific technical writing and documentation 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 Two (2) years of experience in areas of science related to heart, lung, and blood research Superior program management skills, as well as senior level scientific and/or technical gravitas Experience involving early translational, pre-clinical, and/or clinical research-related projects Demonstrated ability to lead scientific research projects or clinical trials by overseeing and integrating all aspects of the effort, setting deadlines, assigning responsibilities, monitoring and summarizing progress of project and program Ability to lead early translational research initiatives associated with novel or emerging therapies Familiarity and experience with federal government programs Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs) Ability to independently manage and prioritize multiple complex projects Ability to work in a busy setting, both independently and within a team Ability to communicate effectively with executive level personnel 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 within the program Ability to manage customer expectations, meet the customer's needs, and to work and manage a schedule Willingness to perform tasks that may fall outside of the normal daily responsibilities 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 Rockville, MD, USA
Nov 14, 2019
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 Work individually and as a team to design, develop, and test software engineering solutions for the biomedical application development center in support of cancer research Work with the software engineering technical lead and management to prioritize feature development and release Document and diagram development artifacts Provide end users with engineering support in a timely manner BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation, in computer science or computer technology 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 Programming experience with Python that interact with a SQL/NoSQL database in the AWS Cloud environment Understand the importance of test-driven development and how its incorporated into the software development cycle Experience developing distributed system and have a good understanding of event-based and microservice architectures Possess good oral and written communication skills. Demonstrate the ability to present complex ideas to technical lead 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 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 Frederick, MD, USA
Nov 14, 2019
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. KEY ROLES/RESPONSIBILITIES Support manufacturing laboratory functions Maintain bacterial and mammalian cell cultures Operate/troubleshoot single use and stainless-steel bioreactors, benchtop lab equipment, GMP autoclaves, and other associated equipment Follow standard operating procedures Complete batch production records under current good manufacturing practices Document in detail, through the use of batch production records, the processes and manufacturing steps taken during the procedures Lead production activities in the manufacturing area Train others within the working group and provide feedback to the manager Interface with quality control/quality assurance Write/revise standard operating procedures (SOP) Assist with investigations, write initial deviation responses BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to education requirements, a minimum of five (5) years of progressively responsible job-related experience with progressively responsible job-related experience in a pharmaceutical cGMP environment Experience with cGMP cell culture manufacturing and production equipment Ability to troubleshoot cell culture process and associated equipment, especially experience with bioreactors Ability to assist in complex investigations including root cause analysis and corrective action determination Working knowledge of cGMP's as they relate to manufacturing operations Ability to write and follow standard operating procedures Ability to assist in writing master batch records and complete Batch Production Records under Good Manufacturing Practices Ability to be gown certified Cleanroom and BL2 experience Ability to lift up to 35 pounds and work in a BL2 environment This position may require working on 2 nd or 3 rd shift and weekends as needed Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Previous lead associate experience a plus Ability to interface with Quality Control, Quality Assurance, Materials Management, Facilities and Validation 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 Rockville, MD, USA
Nov 14, 2019
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 Manages the design, development, implementation and maintenance of the bioinformatics functions Oversees the acceptance/denial of patient molecular alterations for inclusion in the MATCH studies Develops novel bioinformatics tools and utilizes emerging web technologies in the analysis of variants Builds and manages a staff of bioinformaticians to curate clinical data for PMACC precision medicine clinical trials and works in collaboration with drug discovery project teams Selects, develops and evaluates personnel to ensure the efficient operation of the function Work with participating clinical laboratories to develop clinical data submission standards Design, develop, deploy clinical data validation workflows Provide well-reasoned proposals on the processing, storage and communication of clinical data to cross-functional project teams Develop timely and accurate clinical reports for our various stakeholders BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) 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 eight (8) years of relevant experience is require Generally, has 4+ years of experience supervising or leading teams or projects A deep familiarity with Biology, Medical Genetics and the curation of medically relevant human disease variants Previous work with clinical trials or precision oncology A thorough understanding of biological data curation, including the importance of data provenance, levels of evidence; ontologies and controlled vocabularies used to annotate biological and clinical data Adept at scripting languages: Perl, Python The ability to keep a project on track and remove roadblocks for the engineers Possess good oral and written communication skills. Demonstrate the ability to present complex ideas to teams and management that is easy to understand Enjoys 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 A background in cancer immunotherapy A Ph.D. Experience NGS data processing and analysis Knowledge of SQL and Non-SQL programming Experience in AWS 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 San Francisco, CA, USA
Nov 14, 2019
Full time
Come work with the Frederick National Laboratory for Cancer Research, managed by Leidos Biomedical Research, Inc. on behalf of the National Cancer Institute (NCI). It is the only U.S. national laboratory wholly focused on research, technology, and collaboration in the biomedical sciences - working to discover, to innovate, and to improve human health. The Strategic and Data Science Initiatives (SDSI) Program is part of the Frederick National Laboratory for Cancer Research Biomedical Informatics and Data Science Directorate. The SDSI program aims to establish new and extend current initiatives and strategic collaborations in computing and data science to address key cancer challenges, accelerate cancer research and advance predictive oncology. The SDSI program leads innovative efforts to impact and accelerate cancer research in multiple areas including increasing application of high-performance computing and AI, strategic use of data science education to build communities of practice, transforming use of large-scale data and cutting-edge data science in cancer research, and developing novel and sustainable collaborations across the NCI, academic, government, industry and international organizations. The Accelerating Therapeutics for Opportunities in Medicine (ATOM) Consortium (atomscience.org) is a public-private partnership with the mission of transforming drug discovery by accelerating the development of more effective therapies for patients. ATOM founding members are GSK, Lawrence Livermore National Laboratory, Frederick National Laboratory, and the University of California, San Francisco. ATOM consortium members are developing, testing, and validating a multidisciplinary approach to drug discovery in which modern science, technology and engineering, supercomputing simulations, data science, and artificial intelligence are highly integrated into a single drug-discovery platform that can ultimately be shared with the drug development community at large. Frederick National Laboratory is hiring a Cancer Drug Discovery Data Science Fellow to work in computationally-driven cancer drug discovery as part of the ATOM Consortium. This position is based in San Francisco, California. ATOM Fellowship Program We are currently accepting applicants for the ATOM Fellowship Program for a one-year appointment beginning early 2020 Applications must include: A brief statement of research interests. The statement of research interests should be no more than one paragraph and should clearly describe how your research background and interests relate to the overall goals of the ATOM Consortium A brief (one paragraph) description of your career goals CV Selected applicants will be expected to give a virtual job seminar describing their current research as part of the application process. Letter of support will be requested from selected applicants' current research advisors. Please read the following information regarding the ATOM program prior to submitting an application! More information about ATOM, the fellowship program, and frequently asked questions can be found here: KEY ROLES/RESPONSIBILITIES Be able to work independently as part of a multi-disciplinary team to support the ATOM consortium's scientific and technical goals Actively participate in cross-disciplinary training and collaboration Create and maintain strong professional relationships with all ATOM stakeholders Foster and nurture collaborative work environment BASIC QUALIFICATIONS Possession of a PhD in Computer Science, Math or Biomedical Science 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. A strong background in any of the following: cancer biology, pharmaceutical or medicinal chemistry, pharmacology, toxicology, drug discovery, computational biology, in silico biology, bioinformatics, systems biology, molecular dynamics, multiscale modeling, machine learning, adaptive learning or high-performance computing Must be able to obtain and maintain a security clearance Expected Competencies: Analytical approach to defining scientific questions Design of scientifically testable hypotheses Interpretation and analysis of data Must be detail-oriented and possess strong organizational and analytical skills with the ability to prioritize multiple tasks/projects Exceptional written and oral communication skills in order to work closely with numerous stakeholders from diverse organizations 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
Nov 14, 2019
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
Nov 14, 2019
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 Manage multiple projects in coordination with other scientific and project management staff, providing 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 knowledge of the most recent literature and scientific presentations relevant to projects This position will be located in Frederick, Maryland. BASIC QUALIFICATIONS Possession of a PhD or equivalent in a 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 the education requirements, a minimum of two (2) years of relevant experience 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 In‐depth understanding of molecular biology techniques, oncology and clinical research Familiarity with patient derived xenograft and pre-clinical drug studies Experience with clinical trials Project Management Professional (PMP) certification Government contracting experience Expected Competencies: 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)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Nov 14, 2019
Full time
The Clinical Pharmacodynamic 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 (NCI). 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. PADIS facilitates mechanistic and performance analysis of putative anti-cancer agents, and therapeutic interventions to clinical applications, 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 KEY ROLES/RESPONSIBILITIES Develop and validate multiplex immunofluorescence assays on fixed tissue sections using state of the art imaging platforms in support of clinical studies and initiatives Design, perform, analyze and present in vitro experiments to test pharmacodynamic marker responses to novel anti-cancer therapeutics in multiple formats, but particularly in multiplex immunofluorescence analysis of tissue-based assays Generate materials and data necessary to support the primary experimental objectives of the program Support development and implementation of multiplex immunofluorescence assays in support of clinical studies and initiatives Design experiments and strategies to test and confirm putative mechanism of action of clinical trial candidate compounds Perform imaging and analysis of multiplex immunofluorescence assays using confocal microscopy or whole slide imaging in support of clinical studies Data analysis and presentation of results from immunofluorescence assay studies on samples ranging from preclinical in vitro cell line experiments to fixed xenograft tissue sections to clinical specimen biopsies Data analysis and reporting of results from clinical specimen biopsies to the NCI Design, test and write detailed technical SOPs for imaging and analysis for transfer to external labs BASIC QUALIFICATIONS Possession of a Doctoral degree from an accredited university according to the Council for Higher Education Accreditation. Foreign degrees must be evaluated for U.S. equivalency. Demonstration of specific training in cancer biology or DNA repair Experience in the design and validation of multiplexed immunofluorescence assays and the ability to work across testing platforms during the assay development process Experience with quantitative image analysis software (Definiens) Experience with fluorescence widefield and confocal microscopy Identification and validation of novel biomarkers Design of cell-based assays to test mechanism of action of candidate compounds Ability to master novel technologies and instrumentation in response to changes in project priorities or breakthrough technological innovations; hands-on instrumentation work Ability to communicate with program lead researchers in a demanding scientific environment through preparation of formal reports Ability to maintain precise records Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience in elucidating mechanism of action of DNA damaging agents and drugs targeted to DNA repair, cell cycle control and apoptosis A record of publication in the refereed scientific literature JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) 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 Candidate is subject to the following 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)
Frederick National Laboratory for Cancer Research Los Alamos, NM 87544, USA
Nov 14, 2019
Full time
The Applied and Developmental Research Directorate (ADRD) provides clinical and biological monitoring, regulatory support, biospecimen processing and storage, assay development, and project management support to the National Institute of Allergy and Infectious Disease (NIAID) and the National Cancer Institute (NCI) clinical programs including the Division of Cancer Treatment and Diagnosis (DCTD). DCTD facilitates development of unique molecules, diagnostic tests, and therapeutic interventions to clinical applications, including distinct molecular signatures for cancer, refined molecular and clinical assays, and state-of-the-art imaging techniques. Specifically, this position will support a collaborative project developing nano-scale laser emitters of intense fluorescence (nLEIFs) for use in fluorescence microscopy to evaluate tumor immunity in patient biopsies. Majority of the work will be conducted at the Los Alamos National Laboratory (LANL) in New Mexico with occasional travel to the Frederick National Laboratory for Cancer Research. KEY ROLES/RESPONSIBILITIES Develop/improve synthetic protocols for nanomaterials production, purification/isolation, and potentially stabilization Develop spectroscopic techniques to record high resolution spectral response of nanomaterials Use various techniques such as electron or atomic force microscopy to understand synthetic parameters to alter high resolution spectral response Generate at least three spectrally unique nanomaterials to prepare for biological studies Support functionalization of nanomaterials with antibodies or similar Support the microscopy of nanomaterials in biologically relevant test systems and comparison to similar fluorescent-based assays Development, validation and implementation of multiplex immunofluorescence assays Manage multiple tasks, design and perform experiments hands-on, interpret data and present results to the program leadership BASIC QUALIFICATIONS Possession of a PhD degree from an accredited college or university (according to CHEA) in materials science, chemistry, engineering, or related field. Foreign degrees must be evaluated for U.S. equivalency. No experience beyond educational requirements is required Expertise in synthetic chemistry and related lab operations (e.g., wet chemistry bench work) Scientific background in optical fluorescence microscopy Excellent communication skills with the ability to communicate with program lead researchers in a demanding scientific environment through preparation of formal reports is essential Ability to maintain precise records Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Polymer and/or nanomaterial synthesis experience Spectral microscopy experience Experience using Matlab, Python, or other data analysis software Familiarity with biomolecules and antibody conjugation JOB HAZARDS Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s). 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. Candidate is subject to the following 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)
Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Nov 14, 2019
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 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
Nov 14, 2019
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 THIS POSITION IS CONTINGENT ON FUNDING APPROVAL 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 Frederick, MD, USA
Nov 14, 2019
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 Nanotechnology Characterization Lab (NCL) serves as a national resource and knowledge base for all cancer researchers to facilitate the regulatory review of nanotechnologies intended for cancer therapies and diagnostics. By providing the critical infrastructure and characterization services to nanomaterial providers, the NCL accelerates the transition of basic nanoscale particles and devices into clinical applications. KEY ROLES/RESPONSIBILITIES The Research Associate I will: Assist NCL scientists in the physicochemical characterization and development of new analytical methods for evaluating nanomedicines Perform daily operation of TEM and TRPS instruments Be responsible for formal reporting of data including presentations Stay abreast of current research techniques and remain knowledgeable in pertinent areas through reading literature and by attending scientific presentations BASIC QUALIFICATIONS Possession of an BA/BS degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) 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 educational requirements, a minimum of two (2) years related biomedical experience Experience with physicochemical characterization of nanoparticles using methods such as TEM, cryo-TEM, TRPS, and QCM-D Ability to perform complex assignments independently as well as work effectively as part of an interdisciplinary team PREFERRED QUALIFICATIONS Experience writing scientific narratives to accompany 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
Nov 14, 2019
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 management, technical leadership, and organize the activities and personnel associated with antibody production and characterization Thrive in a fast-paced work environment in which many demands are placed on the PM Provide technical, administrative, and operational management of assigned projects, including contract and subcontractor management Managing projects and contracts across a variety of subcontractors and scientific collaborators Maintain a high level of customer satisfaction at all times Be accountable to the customer and to Leidos management for the success of the projects and team Create, manage, and control project schedules Perform risk management and monitor project deliverables Ensure adequate communication and consensus building between a wide array of stakeholders Manage all required activities to ensure alignment with multiple schedules and technical requirements Work with the customer to reprioritize activities to refocus work efforts and support activities to address new or changing business needs BASIC QUALIFICATIONS Possession of a PhD or equivalent, from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in Biology, Biochemistry, Biotechnology, or 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 related experience is required Ability to lead meetings and present data Experience constructing and managing a budget Expertise with antibody production Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS 3 years of experience in Project Management Experience with mass spectrometry, including immuno mass spectrometry Familiarity with mass spectrometry-based proteomics methodology Familiarity with federal contracting Strong interpersonal communication skills JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) 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
Nov 14, 2019
Full time
The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused on the design, generation, characterization and application of genetically engineered and biological animal models of human disease, which are aimed at the development of targeted diagnostics and therapies. LASP contributes to advancing human health, developing new treatments, and improving existing treatments for cancer and other diseases while ensuring safe and humane treatment of animals. KEY ROLES/RESPONSIBILITIES The Research Associate I is primarily responsible for performing colony management of rodent colonies and conducting of complex experimental procedures in conventional facilities: Maintenance of rodent colonies by weaning, clipping, tagging, and management of animal colony database Genotyping of animals by PCR strategies Designing optimal breeding strategies Independently scheduling experimental studies Performing experiments including surgical procedures and utilizing experimental compounds and chemical carcinogens Performing injections of compounds or tumor cells via various routes Monitoring phenotypes and treatment responses Collecting blood and tissues Tumor measuring and maintenance of tumor data by relevant software Superb technical proficiency, judgment and organizational skills are required to effectively manage a significant and complex workload Assignments are performed independently with little direct supervision and following all applicable regulations, policies, procedures and standards governing animal welfare Work involves the use of potentially hazardous material or may be located in areas where such materials are used. Work may require the use of personal protective equipment and requires adherence to strict safety protocols Schedule may include weekend and holiday hours BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a biomedical or veterinary sciences 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 laboratory animal technical experience Experience in rodent colony management and associated procedures such as weaning, ear tagging and tail/ear sample collection Understanding of Mendelian genetics Ability to work independently in a fast-paced environment Outstanding organizational, observational, problem solving and computer/data entry skills Excellent communication skills and ability to communicate closely with the NCI customer and with management in a demanding environment Knowledge of Standard Operating Procedures for animal facilities and the basic requirements for maintaining laboratory animals and performing scientific procedures involving animal testing and data collection Ability to lift to 50 lbs. and to wear respiratory protection equipment if necessary Ability to keep detailed and accurate computer records and maintain/update data in computer-based applications/databases Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Basic skills or ability to quickly learn to perform injections via various routes, tissue harvesting and blood collection Ability to multi-task Computer/data entry skills Excellent written and oral communications skills Ability to perform fine surgical techniques Molecular biology skills (DNA extraction, PCR) JOB HAZARDS OR REQUIREMENTS Candidate will be entering an animal facility or have the potential for exposure to animal allergens Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) 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 Candidate is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance Candidate is subject to the following 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)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Nov 14, 2019
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, including studies intended to facilitate the improved diagnosis, prevention and treatment of HIV infection and AIDS, and AIDS related tumors, particularly those associated with other viruses such as KSHV. 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, to international viral epidemiology. 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 AIDS and Cancer Virus Program is in search of a Research Associate (RAIII) who can (i) develop new assays, analyses and methodologies; (ii) generate and formally report data including poster presentations and rough draft manuscripts for publication. The successful candidate must demonstrate the ability to function independently to fulfill these requirements at an extremely high level of performance. Furthermore, the technical experience needed to succeed in this position is proficiency with nucleic acid purification, quantification by real-time PCR, standard and specialized PCR-amplification, and sequencing with subsequent sequence analysis, as well as next generation sequencing methods. The candidate must have demonstrated an extremely high level of technical proficiency, along with the initiative and ability to function independently. This position will act as the de facto lab manager and will be responsible for ordering lab supplies, training new employees, and maintaining equipment all while performing exceptionally at the bench. Complex assignments are performed independently and reported to supervisor/scientist. Will be required to develop new assays or production methods. Will train staff in technical assays. May initiate a research project by setting up a laboratory. Responsible for data triage and quality control evaluations. Responsible for maintaining essential laboratory supplies and equipment. Serves as technical authority in the absence of the lead laboratory scientist. Preparation of research plans, proposals, or new production methodologies. Includes formal reporting of data including presentation and/or publications. Remain knowledgeable in pertinent areas through literature and scientific presentations. Performs other related duties as assigned by a responsible authority. Function independently in a specialized laboratory of research or specialized scientific service, requiring originality and judgment. Independently evaluate the suitability and quality control of research or production assays or tests; supervise a technical staff. Proficiency with nucleic acid purification, quantification by real-time PCR, standard and specialized PCR-amplification, and sequencing with subsequent sequence analysis, as well as next generation sequencing methods; advanced data reporting techniques, mathematics and statistics. Basic laboratory techniques germane to the specialty area (i.e. sterile procedures, safety procedures, instrument operation, etc.). BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) 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 educational requirements, a minimum of eight (8) years related biomedical experience Must be able to obtain and maintain a security clearance JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) 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
Nov 14, 2019
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 RAS Initiative is seeking a hands-on biomolecular NMR spectroscopist to work on protein-ligand interaction analysis, small molecule screening, and structure determination/refinement by NMR The candidate will join the RAS structural biology group within the RAS initiative and will help in maintaining the in-house NMR spectrometer The candidate will be working closely with a highly collaborative team of biophysicists, chemists, biochemists, cell, and molecular biologists to gain new structural insights about the RAS biology as well as on structure-based drug design approaches for small molecule agent optimization The candidate is expected to be able to participate in experimental design and conduct experiments in a priority-driven environment The candidate will be responsible for completing projects independently and as part of a team Work requires the use of personal protective equipment and adherence to strict safety protocols Structure determination by 3D-NMR, structure refinement by NMR, protein-ligand interactions by NMR, small molecule screening by NMR BASIC QUALIFICATIONS Possession of a Ph.D. degree in structural biology, protein biophysics, biomolecular NMR, or in a related discipline from an accredited college or university according to the Council for Higher Education Accreditation. 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 doctorate degree Familiarity with structure determination by NMR and multidimensional NMR techniques Ability to provide NMR support for protein/small molecule interaction analysis Design and conduct NMR experiments, collect and analyze data Familiarity with linux platform and NMR structural biology software such as NMRPipe, Sparky, Xplor-NIH, etc. Detail-oriented, highly organized and excellent communication skills Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Post-doctoral experience in protein NMR Experience with NMR structure determination and SAR by NMR Biomolecular NMR experience (complete NMR assignments of at least one protein) Protein-ligand interactions by NMR Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)