UNITED STATES - CONNECTICUT - GROTON

JOB SUMMARY

• 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

ROLE RESPONSIBILITIES

• 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.

BASIC QUALIFICATIONS

• PhD in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Engineering, Pharmaceutical Sciences, Statistics, or PharmD with related training
• Strong quantitative modeling skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics).
• Experience with R software
• Strong communication skills--written, oral and presentation

PREFERRED QUALIFICATIONS

• Industry experience in Pharmacometrics, Clinical PK/PD and/or Clinical Pharmacology
• Experience with NONMEM or other pharmacometric software
• Experience with other statistical software (e.g., Stan)
• Programming experience (e.g., Python, C++)

ORGANIZATIONAL RELATIONSHIPS

• Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, PRD-Translational Clinical Sciences
• 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: On Premise

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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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