The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support (DSS) is seeking qualified applicants for several Clinical Pharmacologist positions. DSS provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, clinical pharmacology, and environmental safety evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals to approve safe and effective animal drugs. This position will be filled through FDA’s Staff Fellowship program. The appointment is up to 2 years with opportunity for renewal.
This position is located on the Clinical Pharmacology Team within the Division of Scientific Support in the Office of New Animal Drug Evaluation (ONADE). The function of the team is to evaluate the absolute and relative bioavailability of a new animal drug/drug product and the pharmacokinetics (absorption, metabolism, distribution, and elimination) of new chemical entities. You will analyze and interpret these scientific investigations, technical data, opinions, and related information, and make recommendations for Agency action regarding New Animal Drug Applications and Investigational New Drug submissions.
Applicants should have experience evaluating study designs, assay methodology, and sensitivity of the assay method of drug products and pharmacokinetics of chemical entities, performing pharmacokinetics & pharmacodynamics modeling and analysis utilizing software such as WinNonLin, NONMEM, or WinBUGS; and developing written summaries of bioavailability, bioequivalence, dissolution and pharmacokinetic studies.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “American Association of Pharmaceutical Scientists– Division of Scientific Support Staff Fellow Pharmacologist Position”. Questions may also be directed to the CVM Opportunities mailbox.
**Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
FDA is an equal opportunity employer and is a smoke-free environment.
About Food and Drug Administration - Center for Veterinary Medicine
Join the Center for Veterinary Medicine (CVM) in the protection of human and animal health. As part of the U.S. Food and Drug Administration, CVM has regulatory authority over food, food additives, drugs, and devices for animals. These animals include those from which human foods are derived, as well as pet (or companion) animals. We are responsible for regulating the food, food additives, drugs, and devices given to over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. As a high performance organization, we strive for excellence, innovation, and leadership across all operations and occupations. Learn more about why CVM is the best fit for your talents and keep in touch with us about future job and/or internship opportunities. Begin your career with CVM today. Start by visiting here: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/ucm554240.htm.