Pfizer Associate Director, Pharmacometrician in Boulder, Colorado
Develop model informed drug development (MIDD) plans for assigned project(s) in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
Plan, conduct and report quantitative analyses to optimize doses, dosage regimens and study designs throughout clinical drug development.
Identify opportunities where MIDD approaches can advance the understanding of pharmacological activity, efficacy and safety.
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 drug's 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 include PhD or equivalent degree with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics).
Expertise in analysis and programming software (e.g., Nonmem, R).
Experience in pharmacometric analyses
Good communication skills (written, oral).
4 years or more of experience in a quantitative field
Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.
Drug development and/or regulatory experience
Publications in relevant discipline
Good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles
In addition to professional challenge, we offer a culture that supports and encourages ideas, and recognizes individual contribution.
Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical Pharmacology
Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required
Sitting, ability to perform complex data analyses
Other Job Details:
Additional Location Information: La Jolla CA, Boulder CO, United States Remote
Eligible for Employee Referral Bonus
Eligible for Relocation Package
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