Job Purpose/ Summary: 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.
What You'll Do: - 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
What You'll Bring: - 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
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