Pharmacologist/Toxicologist Regulatory Scientist
The Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is the primary intramural center for product development-oriented research efforts to rapidly develop and translate biomedical research into new vaccines and therapeutic products. VRC is seeking a pharmacologist/toxicologist (P/T) regulatory scientist to join its Regulatory Science and Strategy Program (RSSP), which is responsible for the oversight of r]esearch design and product development processes leading to the production of effective vaccine and monoclonal antibody (mAb) candidates.
The P/T regulatory scientist leads and guides VRC’s pharmacology and toxicology strategies and integrates them into VRC’s research design and product development processes. The P/T regulatory scientist’s primary responsibility is verifying that preclinical results demonstrate the safety of VRC candidate Investigational New Drug (IND) products prior to requesting U.S. food and Drug Administration (FDA) authorization to initiate first-in-human clinical studies. The P/T regulatory scientist verifies preclinical safety support for later stages of clinical development. The P/T regulatory scientist drafts pharmacology and toxicology-specific sections of documents to be included in regulatory submissions, drafts proposals for FDA concurrence and advice, incorporates FDA responses into the VRC’s pharmacology/toxicology program, responds to any FDA pharmacology and toxicology questions, and leads the pharmacology/toxicology portion of meetings between VRC and FDA. The P/T regulatory scientist produces comprehensive reports that meet all applicable FDA statutes and regulations and implements FDA guidelines for each category of safety requirements for pharmaceuticals, excipients, and impurities.
The P/T regulatory scientist develops and implements strategies for efficient use of the resources required to move candidate products from the laboratory to clinical studies. The P/T regulatory scientist works closely with intramural cross-functional groups to formulate clinical proof-of-concept and toxicology testing strategies prior to the start of IND-enabling activities to ensure that all studies meet programmatic needs and are designed to fulfill all NIH and regulatory requirements. The P/T regulatory scientist supports VRC laboratories by identifying causes of concern, recommending safety endpoints that maximize the regulatory value of proof-of-concept studies, and providing expert interpretation of pharmacological assays to manage safety concerns. The P/T regulatory scientist identifies pharmacology/toxicology testing strategies to characterize risks and resolve concerns where safety issues are identified, recommending appropriate changes to clinical study protocols as needed, in addition to reviewing, revising, and drafting various regulatory documents to support clinical studies. This position serves as the formal sponsor representative of record, ensuring statements of work and toxicology study protocols comply with FDA guidance and the U.S. Code of Federal Regulations (CFR) Title 21.
If you are ready for an exciting opportunity, please see the detailed job announcement at Scientific Careers at NIH for more information about the position and how to apply.
Visit NIAID Careers for information about working in NIAID’s dynamic atmosphere!
HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, inclusion, and accessibility.
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