Director of Clinical Pharmacology and Pharmacometric
CRYSTAL PHARMATECH INCUnited States
Posted October 8, 2025
Full Time
About the Company
Crystal Pharmatech is a specialized CRO/CDMO founded in 2010 that excels in crystal form and formulation services for small‑molecule drugs. With a global footprint that includes cGMP facilities in the United States, Canada, and China, the company has supported over 1,000 clients and more than 2,000 compounds, delivering expertise in solid‑state research, crystallization, pre‑formulation, formulation development, and manufacturing. Their integrated service portfolio spans developability assessment, solid‑form screening, formulation, and commercial manufacturing, all compliant with FDA, EMA, and NMPA standards. A distinctive feature is the Mol2Med program, a three‑step First‑Time‑Right approach that expedites lead compounds from optimization to Phase I by ensuring robust API forms and scalable processes. Crystal Pharmatech’s culture of precision, collaboration, and regulatory excellence positions it as a trusted partner for efficient, high‑quality drug development.
Job Description
The Director of Clinical Pharmacology and Pharmacometric will apply advanced pharmacometric approaches to support drug development from preclinical through registration. This role involves conducting population PK, PK/PD, and exposure–response analyses, contributing to model-based drug development (MBDD), and preparing high-quality regulatory documentation. The candidate will need to be hands-on with modeling and model validation, and able to collaborate with clients and regulatory agencies.
Requirements
- Lead population PK, PK/PD, and exposure–response/safety modeling.
- Develop and execute modeling and simulation plans for clinical development.
- Conduct noncompartmental PK analyses (NCA).
- Contribute to nonclinical, clinical pharmacology, and pharmacometric sections of protocols, study reports, IBs, and regulatory submissions.
Benefits
- 401(k)
- Bonus based on performance
- Dental insurance
- Health insurance
- Opportunity for advancement
- Paid time off
- Vision insurance
