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Associate Director, Pharmacometrician

Pfizer
Remote friendly (La Jolla, CA)
United States
$135,100 - $225,100 USD yearly
Clinical Research and Development

Role Summary

  • Develops model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
  • Conducts and reports quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
  • Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety.
  • Support and/or develop pharmacometrics tools, automation workflows, software, and related business processes

Responsibilities

  • Provide support in the development of quantitative methodology, pharmacometrics tools, software, hardware, and/or related business processes.
  • With guidance, provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians to create MIDD plans that include assessments of a drugโ€šร„รดs efficacy, safety, and commercial viability.
  • Responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta analysis, and decision analysis for multiple analyses supporting a program.
  • Prepare formal presentations and written reports to Pfizer standards.
  • Contribute to regulatory documents (summary documents, briefing books, regulatory responses)
  • Have a good understanding of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD
  • Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships

Qualifications

  • Required: PhD or equivalent degree with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics)
  • 3 years or more of experience in a quantitative field
  • Expertise in analysis and programming software (e.g., Nonmem, R).
  • Experience in pharmacometric analyses
  • Good communication skills (written, oral).
  • Drug development and/or regulatory experience
  • Publications in relevant discipline
  • Good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • Preferred: Experience using Nonmem, R and/or PsN softwares is preferred.
  • Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.
  • We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc.

Skills

  • Pharmacometric modeling and analysis
  • Statistical programming and data interpretation
  • Interdisciplinary collaboration and communication

Additional Requirements

  • Sitting, ability to perform complex data analyses

Organizational Relationships

  • Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics and Systems Pharmacology, TCS
  • Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required

Work Location and Other Details

  • Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
  • Last date to apply is December 18, 2025
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