- 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.
- 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.
QUALIFICATIONS / SKILLS
- 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.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.