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
Skills Required
- Master's or PhD in a biology-focused science
- 2+ years of related pharmacokinetic or clinical pharmacology experience
- Competence in noncompartmental pharmacokinetic analysis using Phoenix WinNonlin
- Familiarity with non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling
- Excellent oral and written English communication skills
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
