Associate Director, Pharmacometrics
Structure Therapeutics
14 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
The Associate Director, Pharmacometrics will collaborate with cross-functional stakeholders to support discovery, preclinical, and clinical development programs. Lead/support pharmacometrics deliverables for regulatory submissions and health authority interactions, and communicate key results and recommendations. Reports to the Executive Director, Head of Pharmacometrics.
Job Responsibilities
- Support model-informed drug development across discovery and development programs.
- Represent Pharmacometrics on cross-functional teams, providing quantitative input to strategy, dose selection, and trial design.
- Plan, execute, and document pharmacometrics analyses (PopPK, PK/PD, exposure-response modeling, simulation, reporting).
- Develop and maintain Shiny-based applications for data visualization and model-informed workflows (potential AI/ML-enabled features).
- Coordinate external vendors/consultants and review deliverables for scientific quality and timeliness.
- Contribute pharmacometrics content for regulatory submissions and health authority responses.
- Support process improvements (templates, workflows, modeling infrastructure) and other departmental needs.
Core Competencies / Skills
- Strong cross-functional collaboration and communication; present quantitative findings to diverse audiences.
- Strong programming and analytical skills for PK/PD and pharmacometrics analyses.
- Working knowledge of regulatory expectations for pharmacometrics and clinical pharmacology deliverables.
- Strong project management (prioritization, execution, timeline management).
- Ability to manage external partners with judgment.
Qualifications
- Advanced degree (PhD, PharmD, MS) in Engineering, Mathematics, Statistics, Pharmaceutical Sciences, or related field.
- 5+ years relevant drug development experience.
- Hands-on PopPK, PK/PD, exposure-response, and quantitative/statistical modeling.
- Proficiency with NONMEM, R, and one or more of Monolix, Phoenix WinNonlin, MATLAB, or SAS.
- Experience supporting pharmacometrics/clinical pharmacology deliverables for regulatory or health authority interactions.
- Experience with dataset creation/assembly/review/visualization for modeling.
- Preferred: AI/ML in drug development; small-molecule development; cardiometabolic experience (T2D/obesity); PBPK using Simcyp and/or GastroPlus.
Travel
- Approximately 10–15%.
Benefits
- Eligible for annual performance incentive bonus, new hire equity, and ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays including winter shutdown.
Application Instructions
- Apply through the company’s official career page (BambooHR).
The Associate Director, Pharmacometrics will collaborate with cross-functional stakeholders to support discovery, preclinical, and clinical development programs. Lead/support pharmacometrics deliverables for regulatory submissions and health authority interactions, and communicate key results and recommendations. Reports to the Executive Director, Head of Pharmacometrics.
Job Responsibilities
- Support model-informed drug development across discovery and development programs.
- Represent Pharmacometrics on cross-functional teams, providing quantitative input to strategy, dose selection, and trial design.
- Plan, execute, and document pharmacometrics analyses (PopPK, PK/PD, exposure-response modeling, simulation, reporting).
- Develop and maintain Shiny-based applications for data visualization and model-informed workflows (potential AI/ML-enabled features).
- Coordinate external vendors/consultants and review deliverables for scientific quality and timeliness.
- Contribute pharmacometrics content for regulatory submissions and health authority responses.
- Support process improvements (templates, workflows, modeling infrastructure) and other departmental needs.
Core Competencies / Skills
- Strong cross-functional collaboration and communication; present quantitative findings to diverse audiences.
- Strong programming and analytical skills for PK/PD and pharmacometrics analyses.
- Working knowledge of regulatory expectations for pharmacometrics and clinical pharmacology deliverables.
- Strong project management (prioritization, execution, timeline management).
- Ability to manage external partners with judgment.
Qualifications
- Advanced degree (PhD, PharmD, MS) in Engineering, Mathematics, Statistics, Pharmaceutical Sciences, or related field.
- 5+ years relevant drug development experience.
- Hands-on PopPK, PK/PD, exposure-response, and quantitative/statistical modeling.
- Proficiency with NONMEM, R, and one or more of Monolix, Phoenix WinNonlin, MATLAB, or SAS.
- Experience supporting pharmacometrics/clinical pharmacology deliverables for regulatory or health authority interactions.
- Experience with dataset creation/assembly/review/visualization for modeling.
- Preferred: AI/ML in drug development; small-molecule development; cardiometabolic experience (T2D/obesity); PBPK using Simcyp and/or GastroPlus.
Travel
- Approximately 10–15%.
Benefits
- Eligible for annual performance incentive bonus, new hire equity, and ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays including winter shutdown.
Application Instructions
- Apply through the company’s official career page (BambooHR).