Senior Scientist, Clinical Pbpk Modeling

hace 6 días

Barcelona, España AstraZeneca A tiempo completo

**Typical Accountabilities**
- Utilize physiologically-based pharmacokinetic (PBPK) and translational modeling tools to enable clinical PK projections for drug-drug 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**

**Essential**
- Knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
- Demonstrated broad translational development expertise and experience exemplified by 0-4 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 preferred or equivalent (M.Sc./Pharm.D.) 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

**Desirable**
- A reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
- Experience in early and late stage drug development

**Why AstraZeneca?**
Here we are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.

**So, what’s next

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