Pharmacokineticist I - Leeds, United Kingdom
Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptionalpeople from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.
We are seeking a Pharmacokineticist to join our team in Leeds, UK.
It is an office based position however we may consider remote based depending upon level of experience.
The Pharmacokineticist role will review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK and PD analysis and study objectives.
Responsibilities will also include:
- Liaise with the relevant bioanalytical departments over the transfer and quality of PK and PD data.
- In liaison with the Data Management Department compile PK and PD analysis datasets ensuring a full audit trail of data manipulations is maintained.
- Conduct interim PK and PD analyses and interpretation to support dose progression in the Phase I studies performed at Covance CRU or other clinical research units. Close liaison with the Covance Project Manager, Project Physician and Sponsor regarding the study findings will be needed.
- Review and approve Covance CRU analysis plans for allocated studies and attend data review meetings to discuss and interpret study results.
- Conduct non-compartmental PK and PD analyses as specified in the report and analysis plans.
- QC WinNonlin input and output files, derived datasets and PK handover document.
- Liaise with the Statistics Department over the statistical analysis and presentation of the PK, PD and PK/PD data in Tables, Figures and Listings.
- Prepare or review PK and PD analysis methodology sections and where relevant prepare interpretation of PK and/or PD data for inclusion into PK CSR contribution.
- Review Covance CRU reports for allocated studies for content, presentation, scientific interpretation and validity of the PK and PD sections and resolve any issues with the Statistician and Medical Writer before the draft report is issued.
- Respond to QA report audits and Sponsor comments and incorporate QA findings/Sponsor comments into the final report.
- Keep up to date on current developments in all aspects of his/her job and to initiate improvements where appropriate.
- Any other duties as assigned by the Scientific Director.
Education / Qualifications:
- A Bioanalytical Chemistry or a Biological Life Sciences Degree
- Some experience in clinical pharmacokinetic and/or pharmacodynamic analysis.
- An understanding of, and the ability to apply, the principles of GLP and GCP as per the relevant UK Statutory Instruments.
This job was originally posted as www.emedcareers.com/job/960521407