Pharmacometrician Position at Duke Clinical Research Institute
*Duke Clinical Research Institute Pharmacometrics Center of Excellence *
*Pharmcometrician Position Opening*
Duke Clinical Research (DCRI) is seeking a pharmacometrician to join one of
the world’s leading academic clinical research organizations
https://dcri.org/. The Pharmacometric Center of Excellence has a strong
history of both industry and government funding and combines thought
leadership from clinical subspecialists with unique expertise in regulatory
submissions and clinical pharmacology in special populations (e.g.,
children, pregnancy). The candidate will join a multidisciplinary team of
clinical research professionals in a position that combines flexible
working arrangements, cross-disciplinary mentorship, opportunities for
publication, and room for personal growth and career advancement.
The ideal candidate will join cross-disciplinary study teams leading
multicenter clinical trials across therapeutic areas conducted to support
regulatory submissions to the US Food and Drug Administration and other
agencies. As a member of the study teams, the pharmacometrician will
provide scientific expertise in clinical pharmacokinetics to support study
protocol development and analysis planning, perform pharmacokinetic (PK)
and pharmacodynamic (PD) analyses, and prepare reports and integrated
summary documents. Through this role, the pharmacometrician will have
extensive interactions with scientific and clinical experts, operational
leaders, and regulatory scientists to expand their knowledge base and
expertise in regulatory compliant clinical trials. Results of analyses and
trials will be disseminated via peer reviewed publications and
presentations at national and international meetings, with ample
opportunities for the pharmacometrician to author and lead author
publications.
*Work Performed*
Application of 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. There will
be a focus on the evaluation and implementation of innovative trial designs
to enhance the efficiency and provide better informed decision-making.
Evaluation and understanding of 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.
*Education/Training:*
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Work requires a minimum of a PharmD, MD, PhD in pharmaceutical sciences
or pharmacology.
-
Graduation from an accredited postdoctoral clinical pharmacology program.
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Or an equivalent combination of relevant education and/or experience.
*Experience:*
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Proficient in PK/PD or related analyses and extensive knowledge of
and hands-on
familiarity with software such as winnonlin and NONMEM software required.
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Ability to assemble and format data using programs such as R, SAS, Stata
is a plus.
*About DCRI at Durham, NC*
*The Duke DCRI is the world’s largest academic research organization,
comprised of a multidisciplinary team of more than 1300 individuals;
including 145 physician-investigators, 21 PhD biostatisticians, 35 project
leaders, statistical programmers, site management, and data management
groups. Since 1979, the DCRI has conducted over 1000 clinical trials at
more than 37,000 sites in 65 countries, involving more than 1.2 million
patients. *