Camris

Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.. Review toxicology protocols along with reviewing non-clinical protocols for completeness and compliance with FDA current Good Laboratory Practice (GLP) and applicable regulations.. Ph. D. in toxicology, biology/pharmacology, with at least 10 years related experience with vaccines and other biologics.. Experience specifically supporting drug discovery research and development from a toxicology standpoint.. Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.

scientific program manager

Overview We are seeking a Sr. Scientific Program Manager to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in your career and apply below to help us make a difference. CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities<ul><li>Provide recommendations on optimal non-clinical strategies to advance candidate products to the clinic.</li><li>Work closely with cross-functional groups to formulate non-clinical proof of concept and toxicology testing strategies prior to the start of any IND-enabling activities to ensure that the studies are meeting the program’s needs and are designed to fulfil regulatory requirements.</li><li>Communicate regulatory information to multiple departments and ensure that the information is interpreted correctly.</li><li>Successfully interact with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and explain those recommendations to VRC Leadership.</li><li>Facilitate communication and collaboration internally and/or externally (i.e. vendors/CRO) to ensure mutual clarity amongst multidisciplinary teams and accuracy and suitability of documents/reports for regulatory submission.</li><li>Maintain current knowledge of relevant domestic and international regulations, including proposed final rules and guidance documents.</li><li>Review toxicology protocols along with reviewing non-clinical protocols for completeness and compliance with FDA current Good Laboratory Practice (GLP) and applicable regulations.</li><li>Develop and integrate timelines for non-clinical activities with overall program timelines and VRC goals, in close coordination with Program Management, CMC, Clinical, Regulatory groups and other stakeholders.</li><li>Work together with Regulatory personnel and subject matter experts to author relevant sections of regulatory submission documents (pre-IND and IND) as well as the nonclinical section of Investigator’s Brochures.</li><li>Prepare and/or review all IND non-clinical reports, including toxicology reports from vendors/CRO for submission to the regulatory authorities.</li><li>Provide responses to regulatory agencies' comments regarding non-clinical research or potential pre-IND and IND submission issues.</li><li>Collaborate with strategic planning group during contract negotiation to provide insight and guidance regarding scope of work pertaining to non-clinical/toxicology studies.</li><li>Assist CROs and other external resources and ensure quality results are delivered. This includes study design, protocol development, coordination of study materials, data interpretation, report review and approval.</li><li>Develop and maintain SOPs, in collaboration with relevant subject matter experts, for non- clinical/toxicology studies, including their review and approval processes.</li></ul> Qualifications<ul><li>Ph.D. in toxicology, biology/pharmacology, with at least 10 years related experience with vaccines and other biologics.</li><li>American Board of Toxicology (DABT) required.</li><li>Regulatory Affairs Certificate preferred.</li><li>Experience specifically supporting drug discovery research and development from a toxicology standpoint.</li><li>Experience in designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.</li><li>Demonstrated success managing interactions with external CROs, consultants and other contract organizations is a plus.</li><li>Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.</li><li>Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player.</li></ul> CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required. Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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