Pharmacokinetic Scientist
PharmaClinical ResearchRegulatory AffairsQuality Assurance
Job description
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are looking for a full-time Pharmacokinetic Scientist to join our Clinical Pharmacology team. This role may be based at either our Lincoln, NE, or Montreal, Canada facilities. Remote working relationships may be considered based upon experience. The Pharmacokinetic Scientist will assist with pharmacokinetic data analysis, scientific interpretation of study results, clinical report writing, and interactions with clients. Essential Functions
Data analysis and interpretation
Perform PK analyses independently
Assist with PD analyses
Interpret PK and statistical results and findings independently
Perform QC reviews as assigned
Write and review reports as assigned
Prepare PK data/report files for electronic filing of projects for submission to regulatory agencies
Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects
Other responsibilities Interact with clients alongside or under direction of a senior scientist, as needed
Prepare internal presentations Requirements
Master’s or PhD degree in a biology-focused sciences related field with 2+ years of related experience required
Competence in performing noncompartmental pharmacokinetic analysis with software applications such as Phoenix WinNonlin
Familiarity with processes and applications related to non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling is an asset
Excellent oral and written skills (English language) required
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