Senior Pharmacokineticist / Clinical Pharmacologist
- Experience Level
- Experienced (non-manager)
The Senior Pharmacokineticist is responsible for Analysing and reviewing data and offering scientific advice.
- Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK and PD analysis and study objectives.
- Supervision of less-experienced Pharmacokineticists within project activities.
- Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
- Perform QC/review of analysis.
- Responsible for development of PK Analysis Plans, to include methodology, definition of derived variables and data-handling rules.
- Responsible for PK and PD deliverables within assigned projects.
- Conduct non-compartmental PK and PD analyses as specified in the report and analysis plans.
- Conduct compartmental modelling/simulation of PK, PD and PK/PD data and provide interpretation of the results
- Responsible for PK and PD input to reports including Clinical Study Reports
- Provide PK and PD guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for PK and PD input to protocol.
Candidates will need;
Bioanalytical Chemistry or a Biological Life Sciences Degree
- Significant postgraduate experience in the application of PK and PD to clinical trials
- Proficient in compartmental /non-compartmental data analysis
- Specialist in WinNonLin
- The ability to work to tight deadlines while maintaining high standards.
- A good knowledge of Clinical Development.
- Competence in the preparation of Pharmacokinetic Analysis Plans, analysis, reporting, etc., across a variety of trials.
- Ability to explain PK and PD concepts to non-pharmacokineticists.
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