Associate Director, Clinical Pharmacology
Scorpion Therapeutics, Brisbane, California, United States, 94005
Role Summary
The Associate Director in the Clinical Pharmacology group will contribute to pharmacometric efforts across early and late-stage programs. This role involves developing and executing PK/PD modeling and simulation activities (including population PK/PD, PBPK, and QSP), analyzing data, and presenting findings to optimize doses and study designs. The candidate will author and review clinical pharmacology documents for regulatory submissions and interact with multiple functions across the organization. This onsite position is based in Brisbane, CA. Responsibilities
Utilize quantitative approaches to impact model-informed drug discovery and development, including human dose projections and dose regimen optimization Lead pharmacometric workstreams such as noncompartmental analyses, exposure–response analyses, population PK/PD modeling, PBPK modeling, and QSP modeling, and run model-based simulations Conduct exploratory modeling activities to support decision-making and clinical strategy Collaborate across functions and oversee contract vendors to advance pharmacometric efforts Oversee and contribute to clinical pharmacology sections of study protocols, SAPs, CSRs, PK/PD reports, and development plans Author and review clinical pharmacology documents for regulatory submissions or responses Identify state-of-the-art quantitative approaches for project applications, including AI/ML techniques Qualifications
PharmD or PhD or MS in a field related to Pharmacometrics with 8+ years of industry experience in Pharmacometrics, Clinical Pharmacology, or Quantitative Systems Pharmacology Extensive hands-on experience in modeling and simulation techniques (population PK/PD, PBPK, or QSP) Exceptional oral and written communication skills and strong problem-solving abilities Experience authoring and reviewing clinical pharmacology documents for regulatory submissions or responses Proven ability to operate effectively in a dynamic, team-oriented environment with emotional intelligence High proficiency with software and data analysis packages (e.g., R, WinNonlin, Simcyp, GastroPlus, Monolix, NONMEM) Onsite position based in Brisbane, CA Additional Requirements
Onsite in Brisbane, California
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The Associate Director in the Clinical Pharmacology group will contribute to pharmacometric efforts across early and late-stage programs. This role involves developing and executing PK/PD modeling and simulation activities (including population PK/PD, PBPK, and QSP), analyzing data, and presenting findings to optimize doses and study designs. The candidate will author and review clinical pharmacology documents for regulatory submissions and interact with multiple functions across the organization. This onsite position is based in Brisbane, CA. Responsibilities
Utilize quantitative approaches to impact model-informed drug discovery and development, including human dose projections and dose regimen optimization Lead pharmacometric workstreams such as noncompartmental analyses, exposure–response analyses, population PK/PD modeling, PBPK modeling, and QSP modeling, and run model-based simulations Conduct exploratory modeling activities to support decision-making and clinical strategy Collaborate across functions and oversee contract vendors to advance pharmacometric efforts Oversee and contribute to clinical pharmacology sections of study protocols, SAPs, CSRs, PK/PD reports, and development plans Author and review clinical pharmacology documents for regulatory submissions or responses Identify state-of-the-art quantitative approaches for project applications, including AI/ML techniques Qualifications
PharmD or PhD or MS in a field related to Pharmacometrics with 8+ years of industry experience in Pharmacometrics, Clinical Pharmacology, or Quantitative Systems Pharmacology Extensive hands-on experience in modeling and simulation techniques (population PK/PD, PBPK, or QSP) Exceptional oral and written communication skills and strong problem-solving abilities Experience authoring and reviewing clinical pharmacology documents for regulatory submissions or responses Proven ability to operate effectively in a dynamic, team-oriented environment with emotional intelligence High proficiency with software and data analysis packages (e.g., R, WinNonlin, Simcyp, GastroPlus, Monolix, NONMEM) Onsite position based in Brisbane, CA Additional Requirements
Onsite in Brisbane, California
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