Role overview

Qualifications

Master’s or PhD degree in a biology-focused sciences related field
2+ years of related experience
Competence in performing noncompartmental pharmacokinetic analysis with software applications such as Phoenix WinNonlin
Excellent oral and written skills (English language)

Responsibilities

Assist with pharmacokinetic data analysis
Perform PK analyses independently
Write and review reports as assigned
Prepare PK data/report files for electronic filing of projects for submission to regulatory agencies

Key facts

Remote from: Canada, California (USA), United States
Full time
Mid-level (2-5 years)
Physicist
English

Hard skills

Medical Writing Statistical Inference Life Sciences Client Services

Other skills

Communication

About the company

Celerion

Pharmaceuticals

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

Company details

Company typeLarge

IndustryPharmaceuticals

Company size1001 - 5000

Links

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Job description

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