Senior Pharmacokenticist
Job in
Olathe, Johnson County, Kansas, 66051, USA
Listed on 2026-08-11
Listing for:
Priority Dispatch Corp.
Full Time
position Listed on 2026-08-11
Job specializations:
-
Research/Development
Research Scientist, Data Scientist, Clinical Research, Medical Science -
Healthcare
Data Scientist, Clinical Research, Medical Science
Job Description & How to Apply Below
Senior Pharmacokineticist
REPORTS TO:
Associate Director, PharmacokineticsDIRECT REPORTS:
Not Applicable
POSITION SUMMARY:
The Senior Pharmacokineticist serves as the lead or support for clinical Pharmacokinetic (PK) and Pharmacodynamic (PD) (hereafter referred to as “PK”) planning, analysis, and interpretation in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).
KEY RESPONSIBILITIES:
Participate in the protocol development, including study design, endpoints selection, sample size determination, and writing/reviewing the PK analysis methods sections
Support Case Report Form (CRF) design and review relevant data management documents
Develop PK portion of Statistical Analysis Plan (SAP) or PK Analysis Plan(PKAP) along with relevant Tables, Listings, Figures (TLF) shells
Analyze, interpret, summarize, and present PK data to sponsor and/or medical writer for use in Clinical Study Report (CSR) or other summary reports
Conduct Quality Control (QC) review of PK analyses, text, and outputs (e.g., PK TLFs)
Assists in the development of SOPs and guidelines for the PK department
REQUIRED QUALIFICATIONS:
PharmD or PhD in pharmacokinetics or related field with 3+ years clinical research experience in pharmaceutical/biotech industry (or MS with commensurate experience)
Competence in performing noncompartmental analysis, including experience with software applications (e.g., Phoenix Win Nonlin or R)
Knowledge of PK/PD principles with relevant experience in multiple therapeutic areas
Understanding of statistical methodologies used in clinical trials and interpretation of results
Knowledge of FDA/ICH regulations/guidelines
Excellent verbal and written communication skills, and interpersonal skills
PREFERRED QUALIFICATIONS:
Experience with additional software for the generation of PK outputs (e.g., SAS, R)
Additional knowledge and/or experience in the application of routine PK compartmental modeling software systems and/or physiologically-based PK modeling
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Position Requirements
10+ Years
work experience
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