Cambridge, UK
Posted by: Astra Zeneca
12 Apr
11 Jun expires

Clinical Pharmacometrician, Early Clinical Development

Cambridge, UK
Job Description

This is a scientific job with responsibility for translational modelling, population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. With support from the Principal Pharmacometrician and the TA lead, the incumbent will be responsible for integrating and analysing internal (and external) data to support interpretation and decision making at the study level and with some support at the project level.

Typical Accountabilities

  • Accountable for specialist data integration, analysis, interpretation, and reporting of M&S results at the study level
  • Accountable for executing state-of-the-art M&S techniques with direct value for the project
  • Use of M&S to influence study designs and go/no go decisions
  • Development of (mechanistic) drug-disease models to support projects within a specific disease domain
  • Contribute to regulatory documents and interactions (written)
  • Presentation of M&S results in internal and external forum
  • Contribute to internal initiatives to develop the pharmacometric subject area including its processes
  • Participation in peer review of ongoing activities, reports and presentations
  • Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s
Job ID Reference
Desired Skills & Experience
  • PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
  • Relevant regulatory experience (written)
  • Training and experience with PK and statistical software (NonMem, R, Stan, Winbugs ,SAS, Monolix , Phoenix, WinNonlin)
  • Demonstrated expertise in pharmacometrics, including PK, PKPD and/or statistics
  • Strong quantitative skills (e.g. experience in population modelling, statistics, systems and translational pharmacology modelling).
  • Expert knowledge of pharmacokinetics and Model-Based Drug Development
  • Demonstrated broad translational and clinical development expertise and experience exemplified by 3-6 Years of drug development experience, with emphasis on Clinical Pharmacometrics
  • Demonstrated ability to identify, develop and execute Pharmacometrics activities at a project level
  • Good oral and written communication skills
  • Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology
  Gaithersburg, Maryland, USA
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
 Cambridge, UK