Director Pharmacometrics/Clin.Pharmacology

Job Summary

• Provide pharmacometric expertise and leadership to projects.
• Develop 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.
• 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.
• Acts as Subject Matter Expert (SME), including proactive support and development of quantitative strategy, methodology, software, hardware, and related business processes, in addition to training for colleagues in the global clinical pharmacology organization

• 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 supporting a program.
• Prepare formal presentations and written reports to Pfizer standards.
• Contribute to regulatory documents (summary documents, briefing books, regulatory responses)
• Stay abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD
• Contribute or lead 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.
• Train, develop, and mentor less experienced Pharmacometricians or other clinical pharmacology colleagues.

BASIC QUALIFICATIONS

• 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).
• Demonstrated experience in pharmacometric analyses
• Experience in drug development
• Good communication skills (written, oral).
• 8 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

• Strong publication record in relevant discipline
• Experience with regulatory submissions
• Good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.Relocation support available

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

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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.

Medical

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