ROLE SUMMARY

In research and development at Pfizer, model informed drug development (MIDD) plays an important role in understanding drug safety and efficacy. As a pharmacometrician, you will work with multidisciplinary teams where you will use quantitative methods to provide context on study results and answer team questions during clinical drug development. While your primary therapeutic area will include cardiovascular and metabolic diseases, you may have opportunities to work on projects outside these areas. Your work will directly support decisions during drug development and ultimately contribute toward delivering breakthroughs that change patients' lives.

JOB RESPONSIBILITIES

• 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, quantitative knowledge management, decision analysis, and MIDD strategy in collaboration with partners.
• With guidance, provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians, and other scientists to create MIDD plans that include assessments of a drug's efficacy, safety, and commercial viability.
• Prepares formal presentations and written reports to Pfizer standards.
• Author, contribute, and perform technical quality control checks for regulatory documents (modeling reports, summary documents, briefing books, regulatory responses).
• Stays abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications.
• 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.
• May train, develop, and mentor less experienced pharmacometricians or other colleagues in systems pharmacology, clinical pharmacology or translational clinical sciences.
• Contribute to pharmacometrics' ability to act as a conduit for cross learnings within/across the clinical development organizations. Promote, educate, and mentor others in application of quantitative techniques, best practices, MIDD, and share experiences through appropriate local and global discussions.

• PhD, PharmD, or equivalent, including expertise in one or more areas (e.g., pharmacometrics, clinical pharmacology, pharmacokinetics, pharmaceutical sciences, biostatistics, applied mathematics, or related discipline).
• 0 to 4 years' experience in the quantitative field
• Strong science and quantitative analysis background, with good working knowledge of pharmacokinetics, pharmacology, pharmaceutics, and/or statistics.
• Basic understanding/knowledge of biology, physiology/pathophysiology, and drug research & development process
• Experience using R and NONMEM (or equivalent software, e.g. Monolix, nlmixr2, Pumas)
• Good communication skills (written, oral presentation)
• Candidates from alternative backgrounds (e.g., mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.

• Industry or regulatory experience in pharmacometrics, clinical PK/PD, clinical pharmacology, or systems pharmacology.
• Other relevant software experience (e.g. PsN, mrgsolve, LaTeX, Rmarkdown, Stan)
• Experience in clinical trial simulation, machine learning, biostatistics, Bayesian methods, or literature meta-analyses/model-based meta-analyses
• Candidates with significant (3-5 years) experience will also be considered. Position role and title (e.g. Associate Director) will be commensurate with type and years of experience.

• Reports to Internal Medicine Pharmacometrics Group Leader within the line organization of Pharmacometrics and Systems Pharmacology, Translational Clinical Sciences
• Matrixed relationships particularly with clinical pharmacology leads, clinicians, statisticians, colleagues from programming groups and other groups as required

• Ability to perform complex data analysis

• Ability to travel for business as necessary
• Availability for business meetings in the US Eastern Time Zone