Director, Modeling and Simulation

The role

This person will provide leadership and hands-on support for PK/PD/QSP modeling across a drug discovery portfolio. They will partner with platform companies to translate scientific ideas into therapies and support clinical translation and regulatory interactions.

What you will do

• Identify modeling needs and required data with cross-functional teams
• Help de-risk program questions related to safety and efficacy
• Inform TCP and/or TPP
• Provide guidance for pre-clinical in vitro and in vivo studies
• Test MoA-related hypothesis
• Conduct competitor analysis
• Support clinical translation of pre-clinical data including FiH dose predictions
• Inform target prioritization
• Support regulatory interactions through model-informed drug development approaches
• Develop QSP and PK/PD models for various modalities and therapeutic areas

Required qualifications

• PhD in pharmacology, engineering sciences, (bio-)physics or applied mathematics
• 5+ years of experience in QSP and/or PK/PD modeling
• 8+ years including direct experience managing scientists and/or CRO relationships
• Advanced experience in QSP modeling workflows
• Deep understanding of mechanistic, physiologically-based modeling principles
• Biological subject matter expertise in at least one disease area
• Programming skills (e.g., R, Python, Matlab)
• Hands-on modeling experience using Simbiology, NONMEM, Monolix, Pumas, or similar software packages
• Experience supporting drug discovery programs including due diligence and early feasibility assessments
• Excellent oral and written communication skills

Nice to have

• Familiarity with population PK/PD (e.g., nonlinear mixed-effects, Bayesian methods)
• Experience with AI-supported and/or agentic modeling workflows
• Track record of representing scientific work externally (e.g., publications, conference presentations, scientific advisory interactions)

Benefits

• Healthcare coverage
• Annual incentive program
• Retirement benefits

About the company

Flagship Pioneering is a scientific innovation engine that originates and builds platform companies and products. They unite life science innovation, company creation, and capital investment to create breakthroughs.