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ROLE SUMMARYDevelop 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.
ROLE RESPONSIBILITIESWith 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.
BASIC QUALIFICATIONSQualifications 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 QUALIFICATIONSDrug 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 RELATIONSHIPSReports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical PharmacologyMatrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as requiredPHYSICAL/MENTAL REQUIREMENTSSitting, ability to perform complex data analysesOther Job Details:Additional Location Information: La Jolla CA, Boulder CO, United States Remote
Eligible for Employee Referral Bonus
Eligible for Relocation Package
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 ActPfizer 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 EligibilityPfizer 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.Medical#LI-PFE
