Director, Modeling Informed Drug Development

CTI Clinical Trial and Consulting Services•Covington, KY

11d•Hybrid

About The Position

The Director, Model Informed Drug Development/ Consulting is a senior individual contributor responsible for leading modeling and simulation activities within drug development programs. The incumbent applies advanced pharmacometric methodologies to support dose selection, study design, and regulatory decision-making. This role combines deep technical expertise with scientific leadership, ensuring high-quality execution of modeling activities and contributing to the integration of model-informed strategies into clinical development.

Requirements

Ph.D. in pharmacometrics, clinical pharmacology, statistics, engineering, or related field
At least 6 years of experience in modeling & simulation
Strong hands-on experience with NONMEM or equivalent tools
Proficiency in statistical programming (R, SAS, etc.)
Experience contributing to regulatory documentation and analyses
Demonstrated ability to independently lead technical workstreams

Responsibilities

Independently execute advanced PK/PD, population PK, and exposure–response analyses
Lead modeling strategy aligned with project objectives and regulatory expectations
Apply industry-standard modeling and simulation methods and tools
Provide technical leadership and ownership of modeling analyses and conclusions
Support dose selection, study design, and translational modeling strategies
Review and quality-check deliverables prepared by junior staff
Collaborate closely with clinical, statistical, and regulatory teams
Contribute to preparation of regulatory documents and responses involving modeling
Mentor Scientists and Senior Scientists in modeling and simulation approaches
Participate in internal knowledge sharing and best practice development