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
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com
Why CTI?
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
- Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
- We will never communicate with you directly via Microsoft Teams Messaging or by text message
- We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Veterans/Disabled
PhD in relevant field, 6+ years modeling & simulation experience, hands-on NONMEM and statistical programming (R,SAS), regulatory submission experience, ability to lead technical workstreams.
Key Responsibilities
- executing analyses
- leading modeling
- mentoring staff
Skills & Tools
NONMEM, R, SAS
Job Details
- Category: Research and Development (R&D)
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Covington, Kentucky, United States
- Languages: English
Benefits
- Generous paid time off
- Tuition reimbursement
- Generous parental leave
About CTI Clinical Trial and Consulting Services
A global clinical contract research organization supporting drug development from concept through commercialization. — Industry: Healthcare