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(Associate)Director,Pharmacometrics
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“(Associate) Director, Pharmacometrics. Skills: Pharmacometrics (PM) expertise and leadership, model-informed drug development (MIDD) strategies, modeling and simulation (M&S) deliverables, PK (and/or PD) analysis, AI/ML for science/innovation and for productivity. Lead the pharmacometrics (PM) group of ~6 members to support global and/or regional development projects. Provide PM expertise and leadership in model-informed drug development (MIDD) setting for all therapeutic areas in clinical study”
What You'll Achieve.
ensuring all modeling and simulation (M&S) deliverables are based on science with high quality and timeliness; integrate all regional data and investigate ethnic differences for regulatory submissions in China; seek efficiency in M&S process activities
Industry & Context.
scientific judgment; critical thinking; decision-making in ambiguous or data‑limited settings e. g. in early development
What They're Looking For.
Must Have
8+ years of relevant clinical development experience in M&S and clinical pharmacology roles, Adequate people management experience with proven track records as a coach/trainer, Fluent in English (oral and written)
Nice to Have
Decent scientific publication records in peer-reviewed journals in pharmacometrics areas preferred, Research experience and interest with advanced technologies such as AI/ML preferred
What You'll Do.
Lead the pharmacometrics (PM) group of ~6 members to support global and/or regional development projects
Provide PM expertise and leadership in model-informed drug development (MIDD) setting for all therapeutic areas in clinical study design (including dose rationales)
data analyses to learn dose-exposure-response relationships and their variabilities
result interpretations and reporting
Supervise and work with pharmacometricians and clinical pharmacologists in conducting PK (and/or PD) analysis (e. g.
to integrate all regional data and investigate ethnic differences) for regulatory submissions in China
Engage with management
regional and global (internal and external including regulatory) stakeholders to drive MIDD strategies at project and portfolio levels
Establish best practices for M&S process activities to seek efficiency
Implement and explore process and data analysis strategies including AI/ML for science/innovation and for productivity
Guide PM members in career coach and train junior members in applying quantitative methods and PK-PD knowledge to clinical projects
How You'll Work.
Team & Collaboration
Engage with management, regional and global (internal and external including regulatory) stakeholders; work with pharmacometricians and clinical pharmacologists; Guide PM members in career coach and train junior members
Communication Scope
Excellent communication and negotiating skills; fluent in English (oral and written); translate complex quantitative analyses into clear, actionable insights for cross‑functional and senior stakeholders
Process & Methodology
support global and/or regional development projects, drive MIDD strategies at project and portfolio levels, management of stakeholders
Full Job Description
**Summary** Lead the pharmacometrics (PM) group of ~6 members to support global and/or regional development projects, ensuring all modeling and simulation (M&S) deliverables are based on science with high quality and timeliness. **Responsibilities** * Provide PM expertise and leadership in model-informed drug development (MIDD) setting for all therapeutic areas in clinical study design (including dose rationales), data analyses to learn dose-exposure-response relationships and their variabilities, result interpretations and reporting * Supervise and work with pharmacometricians and clinical pharmacologists in conducting PK (and/or PD) analysis (e.g., to integrate all regional data and investigate ethnic differences) for regulatory submissions in China * Engage with management, regional and global (internal and external including regulatory) stakeholders to drive MIDD strategies at project and portfolio levels * Establish best practices for M&S process activities to seek efficiency. Implement and explore process and data analysis strategies including AI/ML for science/innovation and for productivity * Guide PM members in career development; coach and train junior members in applying quantitative methods and PK-PD knowledge to clinical projects **Qualifications** * Ph.D./PharmD/MD in relevant disciplines (pharmacometrics, pharmacology, statistics and mathematics) or other equivalent degrees or knowledge/expertise * Proficiency with data analysis tools such as R and NONMEM, and other software (e.g., MATLAB, Monolix) * 8+ years of relevant clinical development experience in M&S and clinical pharmacology roles * Adequate people management experience with proven track records as a coach/trainer * Excellent communication and negotiating skills with fluent in English (oral and written) * Decent scientific publication records in peer-reviewed journals in pharmacometrics areas preferred * Research experience and interest with advanced technologies such as AI/ML preferred **Sk
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