Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy

Role: Lead the clinical pharmacology and pharmacometrics efforts from early development through late-stage clinical trials (Ph3) to support dose selection, refinement, and regulatory submissions. Responsibilities: develop and execute quantitative pharmacology strategies, perform model-based data analyses including population PK/PD modeling, and serve as the expert for clinical and translational development strategies; contribute to study design, data review, and regulatory interactions; maintain scientific leadership through publications and conferences. Requirements: PhD in Pharmaceutical Sciences, Mathematics, Engineering, or related field; at least 7 years of experience in clinical pharmacology or pharmacometrics; strong expertise in PK/PD modeling, regulatory engagement, with proficiency in NONMEM and R preferred. High-value: experience with clinical pharmacology in gene therapy, CNS, or siRNA modalities; involvement in regulatory interactions; Ph3 clinical development; hybrid work setup in the U.S. with occasional in-person engagements. Collaboration: cross-functional leadership in clinical and translational teams, regulatory agencies, and global stakeholders.