CA (Can be remote, PST hours)
Position Overview
The Director will lead PK/PD and pharmacometric strategies to support the development of novel immunology-based therapeutics. This role integrates preclinical and clinical data to guide dose selection, study design, and regulatory strategy, while working closely with cross-functional teams across the development lifecycle.
Key Responsibilities
- Lead PK/PD modeling, including population PK and exposure–response analyses
- Support candidate selection, first-in-human dosing, and dose optimization strategies
- Collaborate with research, clinical, and biometrics teams to integrate translational data
- Oversee clinical pharmacology studies and manage external partners
- Contribute to regulatory documents (e.g., INDs, protocols, study reports)
- Mentor team members and ensure high-quality scientific outputs
Essential Qualifications
- Ph.D. with 7+ years or M.S. with 10+ years in Pharmacology, PK, or related field
- Strong expertise in PK/PD modeling and immunology-based therapeutics
- Proficiency in tools such as NONMEM, Monolix, R, MATLAB, or Phoenix WinNonlin
- Solid understanding of drug development and regulatory expectations
- Experience managing CROs and cross-functional collaboration
- Strong communication and leadership skills
- Ability to travel as needed for collaboration and program support
