AstraZeneca is a global, science-led biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals. With a strong commitment to innovation, we push the boundaries of science to deliver life-changing medicines to patients worldwide.
Our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team plays a crucial role in drug development by leveraging Model-Informed Drug Development (MIDD) approaches, including PBPK modeling, to optimize clinical trials and regulatory submissions.
Key Responsibilities
As a Senior Scientist in Clinical PBPK Modeling, you will:
- Develop and apply Physiologically-Based Pharmacokinetic (PBPK) models to predict drug-drug interactions (DDIs), pediatric dosing, and special population pharmacokinetics.
- Collaborate with DMPK and Clinical Pharmacology teams to support drug development decisions.
- Validate PBPK models for regulatory submissions (FDA, EMA, etc.) and influence clinical trial designs.
- Stay updated with regulatory guidelines, emerging PBPK science, and industry best practices.
- Communicate findings effectively through internal reports, regulatory documents, and scientific publications.
Essential Qualifications
- PhD, M.Sc., or Pharm.D. in Pharmacology, Pharmaceutical Sciences, or related field.
- 0-4 years of experience in PBPK modeling & simulation (academia or industry).
- Proficiency in PBPK software (SimCYP, GastroPlus, PK-Sim, Phoenix WinNonlin).
- Strong understanding of pharmacokinetics, drug metabolism, and MIDD.
- Experience with regulatory submissions (e.g., DDI reports, pediatric plans).
- Excellent written and verbal communication skills (English).
Desirable Skills
- Experience in early/late-stage drug development.
- Track record of scientific publications in DMPK/Clinical Pharmacology.
- Knowledge of global regulatory expectations for PBPK modeling.
Why Join AstraZeneca?
- Work in a collaborative, science-driven environment with global experts.
- Opportunity to contribute to cutting-edge drug development and regulatory strategies.
- Flexible hybrid work model (minimum 3 days/week in-office).
- Career growth in a company that values innovation, diversity, and lifelong learning.
