- With guidance, contribute to the development of the model informed drug development (MIDD) plans for an assigned project in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
- Conduct and report quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout all phases (first-in-human through post-approval) of clinical drug development.
- With guidance, identify opportunities where MIDD approaches can advance the understanding of pharmacological activity, efficacy and safety
- Provide support in the development and application of state-of-the-art quantitative methodologies, 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 execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis, quantitative knowledge management, 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)
- 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 modeling skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics).
- Experience with R software
- Strong communication skills--written, oral and 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.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. 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.