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Job Details

Pharmacokineticist (Leeds)

Company: Covance
Location: Leeds or home based within UK
Reference: 62851BR
Closing Date: 24 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

We are recruiting for our early phase clinical team in Leeds and are currently seeking to hire a Pharmacokineticist II to provide pharmacokinetic analysis and consultation in support of global clinical trials. This is a permanent, full time position, based in our Leeds office, or remotely in the UK.

Requirements:

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. 

We are recruiting for our early phase clinical team in Leeds and are currently seeking to hire a Pharmacokineticist II to provide pharmacokinetic analysis and consultation in support of global clinical trials. This is a permanent, full time position, based in our Leeds office, or remotely in the UK. 

About the Job:
Within this position, your duties will include: 

  • Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK and PD analysis and study objectives. 
  • 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. 
  • Review available pre-clinical and clinical pharmacokinetic data and provide interpretation and input to study designs. 
  • 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. 
  • Perform peer review of interim reports before distribution. 
  • 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 file, 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. 

For Toxicokinetic Data Analyses: 

  • Conduct non-compartmental GLP TK analyses as specified in the protocol and/or amendments(s). 
  • Assume responsibility of Responsible Scientist or Principle Investigator where assigned. 
  • Perform peer review of TK reports prepared by PI/RS before distribution to the Sponsor/SD 

For All Analyses: 

  • Respond to QA report audits and Sponsor comments and incorporate QA findings/Sponsor comments into the final report. 
  • Conduct PK and PD modeling/simulations to provide data for study design discussions with the Sponsor, Scientific Director or Medical Director. 
  • 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. 

 

About You:

To be successful in this position, you will need to be educated to BSc level in a Bioanalytical Chemistry or Biological Life Sciences discipline. Additionally, you will need to demonstrate: 
Robust demonstrable experience based knowledge of non-compartmental pharmacokinetic analysis, drug metabolism and physiological processes. 


We Offer:
The opportunity to work within an experienced and highly skilled team. 
Covance offers a comprehensive benefits package including health cover, contributory pension and Life Assurance 

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. 
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. 

There is no better time to join us!

 

Keywords:

Pharmacokinetic, PK, drug metaobolism, pharmacodynamic, PD, WinNonlin, clinical ph I, Leeds, UK.

Apply for this job: Pharmacokineticist (Leeds)

Contact Information:

Address:  Covance Leeds
Leeds

England

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