Clinical Pharmacologist II

Typical Accountabilities

• Perform routine M&S work to support drug development projects based on e.g. CDE guidance of model-informed drug development (MIDD); contribute to the implementation of MIDD concepts to support optimal dose/dosing regimen selection
• Conduct population PK-PD, dose-exposure-response analyses to support drug NDA submission; conduct translational/mechanism-based modelling activities for mechanistic understanding of drug candidates of different targets and modalities
• Communicate with cross-functional teams for model interpretations, modeling ideas and results
• Provide pharmacometrics input in regulatory documents (e.g., briefing book, modeling reports for IND/NDA submissions)

Education, Qualifications, Skills and Experience

Essential

• Master/PhD in quantitative disciplines such as pharmacometrics, pharmacology, mathematics, engineering and statistics
• Working knowledge of other areas (pharmacokinetics [PK], pharmacodynamics [PD], biology, medicine, development and regulatory science, etc.)
• Experience and knowledge in constructing mechanistic or mechanism-based models
• Publications in peer-reviewed journals in pharmacometrics areas preferred

Desirable

• Foundation skills with R and NONMEM (both essential) for modeling and simulation (M&S) work; and at least 1 other software, e.g., MATLAB, Monolix, etc.;
• Understanding of related disciplines (e.g., DMPK, toxicology, biostatistics, medical, regulatory) in drug development
• Be able to collaborate within the group and across functions
• Research experience and interest with advanced technologies such as AI/ML preferred

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 authorisation and employment eligibility verification requirements.