Director, Modeling Informed Drug Development

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Execute advanced PK/PD, population PK, and exposure–response analyses independently.

• Lead the modeling strategy in alignment with project goals and regulatory standards.

• Utilize industry-standard modeling and simulation tools and methodologies.

• Offer technical leadership and take ownership of modeling analyses and their conclusions.

• Assist in dose selection, study design, and translational modeling strategies.

• Review and perform quality checks on deliverables prepared by junior team members.

• Collaborate effectively with clinical, statistical, and regulatory teams.

• Contribute to the preparation of regulatory documents and responses related to modeling.

• Mentor Scientists and Senior Scientists on modeling and simulation techniques.

• Engage in internal knowledge sharing and the development of best practices.

⛳️ Requirements

• Ph.D. in pharmacometrics, clinical pharmacology, statistics, engineering, or a related discipline.

• A minimum of 6 years of experience in modeling and simulation.

• Strong practical experience with NONMEM or similar tools.

• Proficient in statistical programming languages such as R, SAS, etc.

• Experience in contributing to regulatory documentation and analyses.

• Proven ability to independently lead technical workstreams.

🏝️ Benefits

• We promote career development through a structured mentoring program and leadership training courses that offer the necessary support for growth.

• Tuition reimbursement and access to a dedicated training department.

• Competitive health benefits and vacation packages.

• Hybrid work-from-home options.

• Paid parental leave.

• Participation in the CTI Cares program.