Role Summary
The Director, Clinical Pharmacology and Pharmacometrics will work with cross-functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pipeline molecules. The position will contribute to translational approaches to inform clinical development and define the optimal dose, route, and regimen. The position will lead pharmacometrics deliverables supporting regulatory submissions and health authority interactions, and will communicate results and key messages to internal teams and, as appropriate, external partners. The position will report to the Executive Director, Head of Pharmacometrics.
Responsibilities
- Support and help advance model-informed drug development (MIDD) across discovery and development programs.
- Represent Pharmacometrics on cross-functional teams, providing quantitative input to strategy, dose selection, and trial design; influence decisions through data-driven recommendations.
- Plan, execute, and document pharmacometrics analyses (PopPK/PKPD/exposure–response), including models, simulations, and reports.
- Develop and maintain Shiny-based applications to enable data visualization and model-based simulation workflows, with potential integration of AI/ML-enabled features as appropriate.
- Coordinate and oversee external vendors/consultants and review deliverables for quality and timeliness.
- Contribute to pharmacometrics elements of regulatory submissions and health authority responses, with guidance from function leadership.
- Support functional process improvements (e.g., templates, workflows, and modeling infrastructure) and other needs (e.g., due diligence) as assigned.
Qualifications
- Education: Advanced degree (PhD, PharmD, MS) in Engineering, Mathematics, Statistics, Pharmaceutical Sciences, or a related field.
- Experience: 7+ years of drug development experience in biotech/pharma (or equivalent combination of industry and relevant consulting experience).
- Demonstrated hands-on experience with commonly applied pharmacometric methodologies (e.g., PopPK, PKPD, exposure–response, MBMA/statistical modeling).
- Proficiency with pharmacometrics and data analysis tools such as NONMEM, R, and one or more of Monolix, Phoenix/WinNonlin, Matlab, SAS (as appropriate for role).
- Experience contributing to clinical pharmacology/pharmacometrics deliverables that support regulatory submissions and/or health authority interactions.
- Experience with dataset creation and data assembly/review/visualization in support of modeling deliverables.
- Experience applying AI/ML in drug development (preferred).
- Experience supporting small-molecule development (preferred); cardiometabolic experience (e.g., T2D/obesity) (preferred); PBPK experience using platforms such as Simcyp and/or GastroPlus (preferred).
Skills
- Strong cross-functional collaboration and communication skills (written and verbal), able to convey quantitative results clearly.
- Strong data programming and analytical skills to deliver high-quality ad hoc PK/PD and pharmacometrics analyses.
- Working knowledge of relevant regulatory expectations for pharmacometrics/clinical pharmacology deliverables.
- Strong project execution skills: prioritization, quality, and timeline management in a fast-paced environment.
- Experience managing external partners and operating with appropriate autonomy and escalation.
Additional Requirements
- Approximately 10–15%, including scientific conferences and periodic travel to company sites as needed (potential travel to China and periodic time in the SSF, CA office).