School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Provides support in the design and preparation of clinical pharmacokinetics development strategies and study protocols, performing pharmacokinetic (PK) and pharmacodynamic (PD) 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.
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.
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.
Work requires a minimum of a PharmD, MD, PhD in pharmaceutical sciences or pharmacology.
Graduation from an accredited postdoctoral clinical pharmacology program
Or an equivalent combination of relevant education and/or experience
Proficient in PK/PD or related analyses and extensive knowledge of and hands-on familiarity with software such as winnonlin and NONMEM software required.
Ability to assemble and format data using programs such as R, SAS, Stata is a plus.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.