Director, Pharmacometrician
PfizerPosition Purpose
• Provides pharmacometric expertise and leadership to projects.
• Responsible for developing 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.
• Responsible and accountable for conducting and reporting 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.
• Acts as pharmacometric Subject Matter Expert (SME), including proactive support and development of quantitative methodology, software, automation, hardware, tools, and related business processes, in addition to training to the global clinical pharmacology organization.
• Responsible for the pharmacometric leadership and support in preparation and defense of regulatory submissions.
Primary Duties
• Contributes to MIDD, complementary to Pfizer processes.
• Responsible for the planning, execution, and reporting of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis, quantitative knowledge management, decision analysis, and MIDD strategy in collaboration with partners.
• Responsible for the development and maintenance of automation tools improving the efficiency of pharmacometric analyses, communications, and decision making.
• Prepares formal presentations and written reports to Pfizer standards.
• Contributes with project teams/partners to regulatory responses, briefing documents, submissions, or other regulatory documents and/or presentations.
• 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.
• Contributes to Pharmacometrics’ ability to act as a conduit for cross learnings within/across the clinical development organizations. Promote, educate, and mentor others in application of quantitative techniques, best practices, MIDD, and share experiences through appropriate local and global discussions.
• Produces and presents quality scientific contributions at external meetings and for publication.
• Responsible for contributions to and/or leading the development/improvement of our tools, automations, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
• May participate in and contribute to global computational sciences community of practice and contribute to business requirements/support of IT colleagues/contractors, systems, tools, and data flow infrastructure to ensure support services to systems and software tools and colleagues are best in class. Produce and present quality scientific papers at external meetings and for publication.
• Prepares and delivers training on quantitative tools, methodologies, software, hardware, and related business processes internally to Pharmacometricians and for the Translational Clinical Sciences organization.
• May train, develop, and mentor less experienced Pharmacometricians or other clinical pharmacology colleagues.
• May organize and manage project deliverables utilizing the appropriate expertise and resources (internally within the company and/or externally within consultant groups and academic institutions).
• May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
• May collaborate with, enable, and influence external key opinion leaders and regulatory authorities in best practices for drug development science.
Training, Education and Experience
• At least 5 years of experience in pharmacostatistical modeling and application of MIDD.
• An interest and experience of pharmacostatistical methods of data analysis and study design are essential.
• Ideal qualifications include Pharm.D, PhD, or equivalent training, or equivalent expertise in one or more areas related to pharmacostatistical modeling (e.g., pharmacometrics, pharmacokinetics, clinical pharmacology, statistics, or related discipline).
• Candidates from alternative backgrounds (e.g., mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.
• Strong science and quantitative analysis background, with good working knowledge of pharmacokinetics, pharmacology, pharmaceutics, and/or statistics.
• Basic understanding/knowledge of biology, physiology/pathophysiology, and drug research & development process.
• Good computational skills.
• Good knowledge of a range of MIDD software (R, NONMEM, STAN, etc.).
• Good communication skills (written, oral presentation).
Competency
• Pharmacometrics: demonstrates thorough understanding, and application, of quantitative modeling and simulation principles.
• Communication Skills: demonstrates excellent verbal and written communication skills.
Organizational Relationships:
• Reports to Pharmacometrics Group Leader or Head of Pharmacometrics and Systems Pharmacology within the line organization of Pharmacometrics and Systems Pharmacology, Translational Clinical Sciences.
• Matrixed relationships particularly with Clinical Pharmacology Leads, QSP modelers, Clinicians, Statisticians, and colleagues from Pharmacokinetics, Dynamics and Metabolism (PDM), and other groups as required.
Work Location Assignment: Hybrid
#LI-PFE
The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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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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. This position requires permanent work authorization in the United States.
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