Senior Clinical PBPK Modeling Scientist Full-time

Pharmacokinetics And Translational Modeling Expert

The ideal candidate will have a strong background in pharmacokinetics and translational modeling. You will participate in implementing innovative and quantitative approaches to advance clinical drug development. Developing, qualifying, and applying mechanistic PBPK models using in vitro, preclinical, clinical, and literature data to support clinical development decisions 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
• Develop fit-for-purpose, qualified PBPK models suitable for internal decision-making and regulatory use, including support for submission documentation and health authority interactions. 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

• PhD degree preferred or equivalent (M.Sc./Pharm.D.)
• Experience using PBPK platforms such as Simcyp, GastroPlus, or PK-Sim, together with scripting in R and/or Python for data analysis, visualization, and workflow automation.
• Familiarity with AI-enabled scientific workflows, such as literature mining, coding assistance, or document summarization in compliant research environments
• Demonstrated broad PBPK expertise and experience exemplified by 1 – 4 Years of drug development experience, with emphasis on PBPK modeling
• Good knowledge in pharmacokinetics, drug-drug interactions, regulatory guidance in clinical pharmacology, modeling and simulation sciences
• 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
• with relevant experience required
• Experience authoring or contributing to PBPK technical reports and regulatory documentation, including submission-ready analyses and responses to health authority queries. 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

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.