CA [Flex Commuter / Hybrid]
Position Overview
The Principal Scientist will lead quantitative clinical pharmacology and modeling strategies to support dose selection, clinical study design, and model-informed drug development across multiple therapeutic areas and drug modalities. This role applies advanced PK/PD, PBPK, and systems pharmacology approaches to guide clinical development and regulatory decision-making.
Key Responsibilities
- Develop and apply PK/PD, PBPK, and QSP models to support dose optimization and clinical development strategies
- Design quantitative approaches for clinical study planning, drug interactions, special populations, and pediatric development
- Integrate modeling results into regulatory submissions and development plans
- Collaborate with multidisciplinary teams to advance model-informed drug development initiatives
- Contribute to regulatory interactions and evaluate emerging technologies, including AI and machine learning, to enhance modeling approaches
Essential Qualifications
- Ph.D., Pharm.D., M.D., or equivalent in Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Engineering, or related field preferred
- 5+ years of industry experience in Clinical Pharmacology and Modeling & Simulation (or equivalent combination of education and experience)
- Expertise in PK/PD, PBPK, QSP, and model-informed drug development (MIDD)
- Experience with regulatory submissions, health authority interactions, and global regulatory guidance
- Proficiency with industry-standard modeling and simulation software
- Strong scientific leadership, communication, and cross-functional collaboration skills
