The Office of Clinical Pharmacology is seeking incumbents to serve as biologists/pharmacologists/chemists in an interdisciplinary position that provides special scientific expertise in the area of biopharmaceutics and pharmacokinetics. The incumbent will consult with members of their division on the use of computers in statistical pharmacokinetic analysis, perform pharmacokinetic analysis, and apply in-depth knowledge of biology, chemistry, pharmacokinetics, physiology, pharmacology/pharmacy, and medical science in the review of Investigational New Drugs (IND), New Drug Applications (NDA), and Forms 5. Experience with bioanalytical methods for proteins analytes and biomarker assays is highly desirable.
Duties and Responsibilities
Reviews a wide range of drugs received from the pharmaceutical industry to determine the adequacy of the bioavailability protocols and resultant data.
Interprets the complex biomedical, pharmacological, and biopharmaceutical aspects of drug bioavailability as determined in clinical studies.
Prepares a comprehensive summary of the protocols and data reviewed for the requesting unit with substantive recommendations for acceptance, defining the conditions under which they should be accepted or rejected.
Provides expertise in pharmacokinetic and drug metabolism, determining and delineating their role in the system being evaluated.
Performs and interprets pharmacokinetic analysis on data submitted in INDs, NDAs, and antibiotic Forms 5.
Prepares a comprehensive summary of his/her reviews and presents substantive recommendations for revision/acceptance/rejection.
Attends professional scientific society meetings to present papers on investigative results, interact with other scientists to remain cognizant of developments in the field, exchange ideas, and develop background data pertinent to the program.
Compiles data to prepare period and special reports relative to the work of the division and manuscripts for publication in professional scientific journals.
Telecommuting is allowed.
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