Associate Director, Pharmacometrician

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 drug‚Äôs 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).
• Required: 3 years or more of experience in a quantitative field.
• Required: Expertise in analysis and programming software (e.g., Nonmem, R).
• Required: Experience in pharmacometric analyses.
• Required: Good communication skills (written, oral).
• Required: Drug development and/or regulatory experience.
• Required: Publications in relevant discipline.
• Required: Good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles.
• Required: Demonstrated 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 software is preferred.
• Preferred: Candidates from alternative backgrounds (e.g. mathematics, engineering, systems biology, medicine) will be considered if they can demonstrate relevant experience and expertise.

Skills

• Pharmacometric analyses
• Model-informed drug development (MIDD)
• Quantitative methodology development
• Cross-functional collaboration
• Regulatory documentation support

Additional Requirements

• Sitting, ability to perform complex data analyses