- Develop model informed drug development (MIDD) plans for assigned project(s) in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
- Plan, conduct and report quantitative analyses to optimize doses, dosage regimens and study designs throughout clinical drug development.
- Identify opportunities where MIDD approaches can advance the understanding of pharmacological activity, efficacy and safety.
- 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's 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 include PhD or equivalent degree with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics).
- Expertise in analysis and programming software (e.g., Nonmem, R).
- Experience in pharmacometric analyses
- Good communication skills (written, oral).
- 4 years or more of experience in a quantitative field
Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.PREFERRED QUALIFICATIONS
- Drug development and/or regulatory experience
- Publications in relevant discipline
- Good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles
In addition to professional challenge, we offer a culture that supports and encourages ideas, and recognizes individual contribution.ORGANIZATIONAL RELATIONSHIPS
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 requiredPHYSICAL/MENTAL REQUIREMENTS
Sitting, ability to perform complex data analyses Other Job Details:
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
- Additional Location Information: La Jolla CA, Boulder CO, United States Remote
- Eligible for Employee Referral Bonus
- Eligible for Relocation Package
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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.