CA/WEST (can be remote)
Position Overview
The Director will lead pharmacometric activities across discovery, preclinical, and clinical development programs, applying model-informed drug development (MIDD) approaches to guide dose selection, study design, and regulatory strategy. This role collaborates closely with cross-functional teams to deliver quantitative insights that support development decisions and regulatory submissions.
Key Responsibilities
- Lead pharmacometric analyses including population PK/PD and exposure–response modeling
- Provide quantitative input to development strategy, dose optimization, and trial design
- Support regulatory submissions and health authority interactions with modeling deliverables
- Collaborate with internal teams and oversee external modeling partners
- Contribute to process improvements, modeling tools, and data visualization platforms
Essential Qualifications
- Advanced degree (Ph.D., Pharm.D., or M.S.) in a quantitative or pharmaceutical science discipline
- 7+ years of experience in pharmacometrics within drug development
- Expertise in PK/PD modeling and exposure–response analyses
- Proficiency with tools such as NONMEM, R, and related modeling software
- Strong communication, analytical, and cross-functional collaboration skills
- Experience supporting regulatory deliverables preferred
- Approximately 10–15% travel may be required
