Clinical Pharmacometrician
Core
Implement quantitative strategy and model-informed drug development (MIDD) for cell therapy products to optimize dosing, patient selection, and program decisions.
Role type
Clinical pharmacometrician (cell therapy)
Builds
Mechanistic and empirical PK/PD models, exposure-response models, and trial designs for cell therapy pipelines.
Domain
Biopharmaceuticals / Cell Therapy / Pharmacometrics
Deliverable
production ML models
Required skills
Population PK/PD modeling, exposure-response modeling, mechanistic modeling, regulatory strategy (FDA MIDD), QSP, Bayesian/adaptive methods, biomarker integration
Preferred skills
AI/ML in pharmacometrics, cell therapy platform experience (CAR T, TCR), disease area expertise (oncology, immunology)
Technologies
NONMEM, Phoenix/NLME, R, SAS, Python, MATLAB
Responsibilities
Build MIDD across cell therapy portfolio; partner with project teams to build population PK, PKPD, and exposure-response models; develop mechanistic and empirical models; ensure modeling strategies align with regulatory expectations; monitor and adopt emerging methodologies; advance leadership through speaking and publications.
Seniority
Mid-level, hands-on IC