Director, Clinical Pharmacology and Pharmacometrics

Structure Therapeutics•South San Francisco, CA

About The Position

Structure Therapeutics develops life‐changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. The Director, 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.

Requirements

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.
Advanced degree (PhD, PharmD, MS) in Engineering, Mathematics, Statistics, Pharmaceutical Sciences, or a related field.
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.

Nice To Haves

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.

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.