Job Description

The ideal candidate will have strong background in pharmacokinetics and translational modeling. You will participate in implementing innovative and quantitative approaches to advance clinical drug development. The position will involve conducting mechanistic PBPK using clinical data to support the clinical development of drug candidates across therapy areas. In addition, you will have opportunities to contribute to broader areas within Clinical Pharmacology & Quantitative Pharmacology (CPQP) as per your experience, interests, and expertise dictate.

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

• 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 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

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.