South San Francisco, California, United States of America
Full Time
3 weeks ago
$225,000 - $290,000 USD
No Visa Sponsorship
Key skills
AssemblyRMATLABAIMLPhoenixLeadership
About this role
Role Overview
Support and help advance model-informed drug development (MIDD) across discovery and development programs.
Represent Pharmacometrics on cross-functional teams, providing quantitative input to strategy, dose selection, and trial design; influence decisions through data-driven recommendations.
Plan, execute, and document pharmacometrics analyses (PopPK/PKPD/exposure–response), including models, simulations, and reports.
Develop and maintain Shiny-based applications to enable data visualization and model-based simulation workflows, with potential integration of AI/ML-enabled features as appropriate.
Coordinate and oversee external vendors/consultants and review deliverables for quality and timeliness.
Contribute to pharmacometrics elements of regulatory submissions and health authority responses, with guidance from function leadership.
Support functional process improvements (e.g., templates, workflows, and modeling infrastructure) and other needs (e.g., due diligence) as assigned.
Requirements
Advanced degree (PhD, PharmD, MS) in Engineering, Mathematics, Statistics, Pharmaceutical Sciences, or a related field.
7+ years of drug development experience in biotech/pharma (or equivalent combination of industry and relevant consulting experience).
Proficiency with pharmacometrics and data analysis tools such as NONMEM, R, and one or more of Monolix, Phoenix/WinNonlin, Matlab, SAS (as appropriate for role).
Experience contributing to clinical pharmacology/pharmacometrics deliverables that support regulatory submissions and/or health authority interactions.
Experience with dataset creation and data assembly/review/visualization in support of modeling deliverables.
Experience applying AI/ML in drug development preferred.
Experience supporting small-molecule development preferred; cardiometabolic experience (e.g., T2D/obesity) preferred; PBPK experience using platforms such as Simcyp and/or GastroPlus preferred.