Director, Modeling Informed Drug Development

🔥 13 minutes ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🔴 Lead

👔 Director

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. • Tuition reimbursement and a dedicated training department. • Generous health benefits and vacation packages. • Hybrid work from home opportunities. • Paid parental leave. • CTI Cares program.