Associate Clinical Pbpk Modeler, Clinical - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

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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