Closing Date: December 17, 2021
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 Clinical Pharmacologist positions. DSS provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, clinical pharmacology, and environmental 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 within the Clinical Pharmacology Team of the Division of Scientific Support, in the Office of New Animal Drug Evaluation (ONADE). The team functions as subject matter experts in the disciplines of pharmacokinetics and biopharmaceutics. Using data submitted from scientific investigations, technical reports, opinion statements, and related information, team members evaluate drug dose-exposure relationships, absolute bioavailability and comparative bioavailability of new chemical entities intended for use in companion and food-producing animal species. In particular, reviewer responsibilities also include the evaluation of proposed pre-approval and post-approval formulation changes on the rate and extent of drug absorption by examining comparative drug concentration- time profiles in the blood or other biological fluid and comparative in vitro dissolution data. Upon completing this analysis, recommendations are made for Agency action regarding New Animal Drug Applications and Investigational New Animal Drug submissions.
To support these responsibilities, applicants should have experience in the evaluation of pharmacokinetic data, including study design, assay methodology and validation, and experience in examining comparative in vitro dissolution profiles. They should have experience using pharmacokinetic software tools such as WinNonLin, NONMEM, or WinBUGS and a demonstrated ability to develop written summaries of their evaluations.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multidisciplinary 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.
The position is located in Rockville, Maryland, Open 11/17/2021-12/17/2021 and is available immediately. The salary range for the GS-12 equivalent level is from $86,335 to $112,240, and for the GS-13 equivalent level from $102,663 to $133,465 based on experience and education. Further information regarding qualification requirements can be found at the following link: http://www.opm.gov/policy-dataoversight/ classification-qualifications/general-schedule-qualification-standards/0400/pharmacology-series-0405/.
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of
“Working at CVM” – Division of Scientific Support Staff Fellow Pharmacologist Position”. Questions may also be directed to the
CVM Opportunities mailbox.