Associate Director - Pharmacometrician

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ROLE SUMMARY

• Develops 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.
• Support and/or develop pharmacometrics tools, automation workflows, software, and related business processes

ROLE RESPONSIBILITIES

• 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

BASIC QUALIFICATIONS

• PhD or equivalent degree with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics)
• 3 years or more of experience in a quantitative field
• Expertise in analysis and programming software (e.g., Nonmem, R).
• Experience in pharmacometric analyses
• Good communication skills (written, oral).
• Drug development and/or regulatory experience
• Publications in relevant discipline
• 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.

PREFERRED QUALIFICATIONS

• Experience using Nonmem, R and/or PsN softwares is preferred.
• Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.

We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc. 

ORGANIZATIONAL RELATIONSHIPS

• Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics and Systems Pharmacology, TCS
• Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required

PHYSICAL/MENTAL REQUIREMENTS

Sitting, ability to perform complex data analyses

Work Location Assignment: Hybrid

#LI-PFE

The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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