SciLucent LLCREGULATORY TOXICOLOGY CONSULTANT (SENIOR-LEVEL) SciLucent LLCREGULATORY TOXICOLOGY CONSULTANT (SENIOR-LEVEL)herndon, VARemote$85,000–$175,000 / yearJob Requirements: Advanced degree (PhD or MS) in toxicology or a related and relevant scientific field 7 or more years' experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, life sciences consulting and/or contract service industries Prior experience and knowledge in working with Contract Research Organizations (CRO) including general study design and conduct, study monitoring, technical and scientific aspects of study execution including common routes of administration and species Must possess current knowledge and expertise in regulated drug development processes Excellent track record of successfully authoring quality nonclinical regulatory documents Knowledgeable in regulatory guidance documents, precedents and GLP regulations Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel Must be detail-oriented, with an ability to think critically and innovatively Demonstrated track record of managing multiple projects and client accounts simultaneously, preferably in a consultancy setting Ability to synthesize complex technical information and present it clearly to diverse audiences. Act as a trusted advisor to drug development clients, providing strategic support on nonclinical strategies and activities Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients Provide oversight and management of program outsourcing activities Review, analyze, and interpret complex scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies Author and/or critically review nonclinical submission packages for scientific content and quality Act as nonclinical representative for Agency interactions and meetings Conduct scientific assessments (e.g., gap analysis, safety assessments) Assist in the preparation of proposals and presentations tailored to client needs and business development goals.
Inotiv, IncNewScientist, Genetic Toxicology Inotiv, IncScientist, Genetic ToxicologyRockville, MD$80,100–$105,500 / yearPlease note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. Reviews and recommends potential assay developments to upper management, and participates in initiatives and/or projects to drive improvement in quality and/or client service.
Tunnell Government ServicesNewToxicologist Tunnell Government ServicesToxicologistWashington, DCRemoteA minimum of five years of experience conducting assessments of risks to human health from exposure to chemicals, chemical hazard identification, and selection of studies for quantitative dose-response and exposure assessments, including assessment of adverse responses and relevant mechanism(s) of material/tissue interactions associated with extractables and leachables from polymers and metal alloys using approaches within the disciplines of toxicology, immunotoxicology, and genetic toxicology. This candidate must serve as a technical authority in the scientific analysis of the safety and effectiveness of medical devices, and provide an authoritative analysis of scientific data submitted to the Agency to support scientific evaluations required for medical device review by FDA.
US Department of Health and Human ServicesRegulatory Scientific Reviewer (Toxicologist) US Department of Health and Human ServicesRegulatory Scientific Reviewer (Toxicologist)College Park, MD$121,785–$191,352 / yearThe Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.
Culmen International, LLCNewPublic Health Analyst Culmen International, LLCPublic Health AnalystSilver Springs, MDExceptional Medical/Dental/Vision Insurance, premiums for employees are 100% paid by Culmen, and dependent coverage is available at a nominal rate (including same or opposite sex domestic partners). Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations.
EWGSenior Scientist EWGSenior ScientistWashington, DCFull timeThe ideal candidate will have a demonstrated commitment to working for the public interest, a strong technical background in toxicology or related field, outstanding interpersonal, oral and written communication skills, and the ability to use the best available science to make informed decisions despite evolving or imperfect information. Responsibilities: Lead in-depth toxicological hazard and risk evaluations for chemicals in EWG Verified products, utilizing GHS criteria, internationally recognized frameworks, read-across methodologies, predictive modeling and AI to address data gaps.
DRT Strategies, Inc.NewClinical Data Scientist, FDA (Jr.) DRT Strategies, Inc.Clinical Data Scientist, FDA (Jr.)Silver Spring, MDFull timeLabeling Review SupportAssist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported, Provide draft safety data analyses on labeling accuracy and completeness for review by FDA staff. DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries.
DRT Strategies, Inc.NewClinical Data Scientist, FDA (Sr.) DRT Strategies, Inc.Clinical Data Scientist, FDA (Sr.)Silver Spring, MDFull timeLabeling Review SupportAssist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported, Provide draft safety data analysis on labeling accuracy and completeness for review by FDA staff. DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries.
United States ArmyCHEMIST (FORENSIC) United States ArmyCHEMIST (FORENSIC)Fort Meade, MD$102,415–$133,142 / yearIn addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below: Specialized Experience: One year of specialized experience equivalent to at least the GS-11 grade level in the Federal service which includes: 1) conducting and analyzing of scientific testing to provide scientific validation of results; 2) analyzing of complex scientific testing results, screening and confirmation; 3) interpreting the quantitative results from the highly specific analytical instrumentation (such as gas or liquid chromatograph/mass spectrometer) to test human urine samples for selected drugs of abuse or drug metabolites; 4) utilizing in-depth knowledge of the field of chemistry, pharmacokinetics and toxicology to solve problems. FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.
Exponent Inc.Managing Scientist (Ph.D. or M.S.) Exponent Inc.Managing Scientist (Ph.D. or M.S.)Washington, DC$131,445–$161,460 / yearIn this role, you will work as part of a multi-disciplinary team of toxicologists, exposure scientists, health risk assessors, food scientists, nutrition scientists, and regulatory consultants providing safety reviews, conducting health risk assessments, and project management to support clients in the food and ingredient industries. For over five decades, we've connected the lessons of past failures with tomorrow's solutions to advise clients as they innovate technologically complex products and processes, ensure the safety and health of their users, and address the challenges of sustainability.
U.S. Department of DefenseNewClinical Laboratory Scientist U.S. Department of DefenseClinical Laboratory ScientistBethesda, MD$85,447–$111,087 / yearIn addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements below: Specialized Experience: One year of specialized experience which includes performing high complexity patient testing (such as chemistry and hematology pre-analytics and automation, chemistry assays, immunoassays, osmolality, sweat chloride, therapeutic drug monitoring, toxicology, serology/ immunology, differentials, coagulation, urinalysis, bone marrows, body fluids, semen analysis, flow cytometry) within a Clinical Pathology Service/Core Laboratory; performing differentials on blood and body fluids; setting up/monitoring quality controls; troubleshooting/performing maintenance on testing instruments; and performing proficiency testing for national accreditation. A Bachelors or graduate/higher level degree from an accredited college/university, including 16 semester hours (24 quarter hours) of biological science (with one semester in microbiology), 16 semester hours (24 quarter hours) of chemistry (with one semester in organic or biochemistry), one semester (one quarter) of mathematics, AND five years of full time acceptable clinical laboratory experience in Blood Banking, Chemistry, Hematology, microbiology, Immunology and Urinalysis/Body Fluids.
IMAGINEEER LLCScientific Data Analyst IMAGINEEER LLCScientific Data AnalystArlington, VAYou will develop and maintain NIH databases, build analytical tools, support computational modeling, and deliver data-driven insights to a multidisciplinary team advancing human-centered biomedical research. PhD in bioinformatics, mathematics, statistics, computer science, data science, or related field with 4+ years of relevant experience OR Master's degree in an equivalent field with 4 years of additional experience .