Associate Clinical Pbpk Modeler, Clinical

hace 2 semanas


Barcelona, Barcelona, España AstraZeneca A tiempo completo

Typical Accountabilities

  • Utilize physiologicallybased pharmacokinetic (PBPK) and translational modeling tools to enable clinical PK projections for drugdrug interactions (DDIs), pediatric and other specific populations, and other clinical development questions
  • Collaborate with Drug Metabolism and Pharmacokinetic (DMPK) Scientists and Clinical Pharmacology scientists to generate these mechanistic models
  • Validate the mechanistic models to the level of being able to be used in Regulatory submissions and to influence the design of clinical trials
  • Communicate clearly and effectively both internally and externally on topics related to PBPK clinical DDI and pediatric and other specific populations predictions
  • Keep up to date with emerging literature, modeling science, and regulatory expectations

Education, Qualifications, Skills and Experience

  • Knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
  • Demonstrated broad translational development expertise and experience exemplified by 04 Years of drug development experience, with emphasis on PBPK modelling
  • Good knowledge in pharmacology, drug targets and core disease areas
  • Demonstrated ability to identify, develop and execute PBPK activities at a project level
  • Good oral and written communication skills
  • Good knowledge of global regulatory, compliance, processes, standards and issues specific to PBPK
  • PhD degree with relevant experience required
  • Relevant regulatory experience (written)
  • Training and experience with PBPK and other relevant software (e.g., SimCYP, GastroPlus, PK-Sim, Phoenix WinNonlin)
  • Fluency in spoken and written English language


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