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Description & Requirement The Life Sciences Operation of the Health Solution Business Unit is seeking a Pharmacologist/Toxicologist Subject Matter Expert (SME) to support the Chemical/Radiological/Nuclear (CRN) Medical Countermeasures group within the Biomedical Advanced Research and Development Authority (BARDA) of Health and Human Services. The CRN group at BARDA maintains a large portfolio of medical countermeasures (MCMs) and diagnostics with the objective to provide suitable products to the Strategic National Stockpile (SNS) through US Government acquisition mechanisms. This full time position will perform duties at the customer site in Washington, D.C. The candidate will report to an SAIC customer-site technical lead, including weekly progress reports. The customer site technical site lead will also provide guidance on USG technical requirements. JOB DESCRIPTION: The SME provides advice on the technical aspects of radiation biology, dosimetry, chemical and physical toxicology, non-clinical and clinical safety study designs, drug pharmacokinetics (PK) and pharmacodynamics (PD), appropriateness of biomarkers, GXP for manufacturing, animal research, animal model development, regulatory path to licensure, cost analysis and Independent Government Cost Estimate (IGCE) computations, and product utility in concepts of operation (CONOPs). In addition, the SME, as part of an oversight team, advises on the technical scope and content of proposals, as well as support financial assessments, in the evaluation and awarding of contracts through the ASPR/BARDA Contracts Office. The SME is required to be knowledgeable of the biophysics, properties, and methods of delivering ionizing radiation, the measurement and interpretation of radiation dosimetry, and an academic background in the pharmacology and toxicology of known therapeutics (drug and biologic) that are clinically useful for modulating both the effects of chemical injury and ionizing radiation injury plus the control of isotopic body burden (decorporation). An understanding of assay validation, GMP manufacturing and the regulatory filing of the NDA/BLA, product stability studies, cold chain and shipping requirements, and a sound understanding of product life cycle are required. Required Experience Academic (research and publications) and Practical (licensing, applied science and experience) experience including : • Animal models • Drug development pharmacology testing • Drug development toxicology testing • Clinical science background • Participation as a team member in advising on regulatory submissions a plus • Experience in handling and use of radioactive materials, nuclear medicine background a plus (i.e. technology licensing; RSO or Health Physics background a plus) • Experience in techniques for dosimetry (exposure) and biodosimetry (absorbed dose); experience in biomarker development and medical device development a plus • Experience in radiation injury, transuranic isotopes, nuclear science, medical management of radiation injury and contamination Responsibilities: Pre-award activities for CRN solicitations: • Provide subject matter expertise for the Contract Officer(s) (CO) on the appropriate pharmacology and toxicology studies, animal and clinical science models, analytical methods, regulatory approaches applicable to an indication and utility of an MCM in chemical • Assist in the preparation of draft Statements of Work and Technical Evaluation Criteria which will be useful in making appropriate USG MCM selections for a medical concern, i.e. ARS or chemical injury • Provide product development cost analyses and generate formal independent government cost estimates (IGCE) for the CO • Provide coordination of the activities of a multi-disciplinary team of scientists with regard to the acquisition process for MCMs • Participate in Technical Evaluation Panels (TEPs) • Prepares Risk Assessment and Mitigation Strategies in coordination with SME and BARDA Risk Mitigation staff • Participate in discussions on the selection and design of studies to be performed, program cost analysis and appropriateness of timelines and project staffing and facilities Post-Award efforts for CRN solicitations: • Serve as an advisor in support of the Project Officer (PO) and the CO, through participation in weekly teleconferences, site visits, review of documents, study designs, analytical approaches, animal models, etc • Support the scientific validity of proposed work and provide supportive solutions as a technical representative for the project to the PO for the CO • Assist in the review of monthly and quarterly progress reports and provide comment on study issues, cost questions and provide recommendations for solutions to identified problems • Provide planning and/or execution of GMP, GLP and/or GCP audits of BARDA contractors and/or subcontractors Other Responsibilities: • The SME shall provide weekly progress reports to BARDA Management on the scope and progress of the CRN program. These reports shall highlight the group as well as individual SME effort for the respective time period, action items within the period, and a forward-looking summary of anticipated work activities, travel, and meeting obligations. • The SME for the CRN group will interact with associated governmental agencies including DHS, NIH, FDA, VA, NRC, DoD, AFRRI, DARPA, DOE, USDA, and EPA and others. Required: An advanced degree in pharmacology or toxicology. Individuals must possess 8-10+ years of experience in microbiology, radiobiology or therapeutic product development. Understanding of the life cycle management of FDA regulated products. Established reputation as a subject matter expert as evidenced by peer reviewed publications, professional associations. Willing to provide on-site support at the offices of BARDA. Outstanding interpersonal, organizational, oral and written communication skills are required; must be able to independently manage projects of moderate complexity. Individuals must possess a proficiency in Microsoft Office Applications (Word, Excel, Project and PowerPoint). Must be willing to travel (not to exceed 20%) to manufacturing facilities, including some international travel. Position requires US Citizenship and ability to obtain a Secret Level Clearance. Desired: Demonstrated ability to interact with associated governmental agencies including DHS, NIH, FDA, VA, NRC, DoD, AFRRI, DARPA, DOE, USDA, and EPA and others is desirable SAIC is a FORTUNE 500® scientific, engineering, and technology applications company that uses its deep domain knowledge to solve problems of vital importance to the nation and the world, in national security, energy and the environment, critical infrastructure, and health. For more information, visit www.saic.com. SAIC: From Science to Solutions® (When applying, please mention this ad in TedJob.com) Think this job inappropriate for the site? Please click here to have our staff review it. |
