- Implements 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.
- May help in providing support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.
QUALIFICATIONS / SKILLSBasic Qualifications:
- 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 EQDD strategy in collaboration with partners.
- Prepares formal presentations and written reports to Pfizer standards.
- Provide Quantitative Clinical Pharmacology expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians and statisticians to create clinical development plans that include assessments of a drug's efficacy, safety, and commercial viability.
- May contribute to project teams/with partners on regulatory documents.
- 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.
- PhD in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Engineering, Pharmaceutical Sciences, or PharmD.
- Strong quantitative modelling skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, literature meta-analyses, clinical trial simulations, statistics).
- Experience using R software.
- Good communication skills (written, oral presentation).
- Industry experience in Pharmacometrics, Clinical PK/PD and/or Clinical Pharmacology
- Experience with Nonmem, PsN, MATLAB or other pharmaceutical software
- Experience with other statistical software (e.g. Stan).
- Programming experience (e.g., Python, C++).
- 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
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
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