Director of Clinical Pharmacology Modeling and Simulation
Core
Lead clinical pharmacology and modeling & simulation for infectious disease assets, combining hands-on quantitative analysis with strategic leadership to inform clinical trial design, dose selection, and regulatory submissions.
Role type
Senior individual contributor (hands-on IC) clinical pharmacologist
Builds
Clinical development plans, regulatory submission packages, and model-based evidence for infectious disease programs
Domain
Pharmaceutical R&D, Infectious Disease, Clinical Pharmacology
Deliverable
production ML models | product features
Required skills
Population PK/PD modeling, Exposure-response analysis, NONMEM, Monolix, R, Regulatory guidance application, Clinical trial design, Dose selection justification
Preferred skills
PBPK modeling, Python, WinNonlin, Simcyp, SAS, MATLAB, Translational PK/PD, Infectious disease domain expertise
Technologies
NONMEM, Monolix, R, Python, WinNonlin, Simcyp, SAS, MATLAB
Responsibilities
Develop population PK/PD and exposure-response models to inform clinical trial design; Select and justify doses and dosing regimens; Present model-based evidence to governance boards and regulatory agencies; Author clinical development and regulatory documents; Collaborate with clinicians, statisticians, and regulatory colleagues; Apply emerging modeling methodologies to improve program efficiency.
Seniority
Senior, hands-on IC
