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Duke University Job Description: |
Job Title: PHARMACOKINETICIST I |
Job Code: 2685 |
FLSA: E |
Job Level: 86 |
Revised Date: 12/21/2022 |
Job Family: JF 05 |
Provides support in the design and preparation of clinical pharmacokinetics development strategies and study protocols, performing pharmacokinetic (PK) and pharmacodynamic analyses, and preparation of clinical study reports and integrated summary documents. Conducts and coordinates the PK/PD analysis or statistical efforts for clinical trials at all stages of drug development.
Evaluates and understands (PK/PD) characteristics absorption, distribution, metabolism, and excretion (ADME) research on compounds, and associated variability of drugs in clinical development, using empiric, mechanistic, and population modeling approaches. Embraces model-based drug development (MBDD)-a mathematical and statistical approach that constructs, validates, and utilizes disease, placebo, exposure-response, and pharmacometric models to evaluate risk and facilitate drug development, in close collaboration with R&D partners. Applies PK/PD techniques during all stages of drug development, including molecule selection, non-clinical dose and regimen selection, first-in-human studies, Phase II dose/regimen selection, and strategic and tactical decision-making for large Phase III clinical studies. Focuses on the evaluation and implementation of innovative trial designs to enhance the efficiency and provide better informed decision-making.
Designs, plans, and executes basic biostatistical components of plans for research and development projects of early-phase clinical studies, including summary statistics of clinical variables and basic inferential statistics.
Performs other related duties incidental to the work described herein.
| Education/Training: | Work requires a minimum of a PharmD, MD, or PhD with knowledge of PK/PD analyses, or a Master's degree in biostatistics with at least 2 years of experience in clinical PK. |
| Experience: | OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE |
| Skills: | Extensive knowledge of winnonlin and NONMEM software required. |
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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