Pfizer, S.A. de C.V
Senior Scientist, Translational Modeling and Simulation
Pfizer, S.A. de C.V, Groton, Connecticut, us, 06349
Senior Scientist, Translational Modeling and Simulation
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.Senior Scientist (R04) – ADME/PBPK ModelingThe individual will be the ADME and PBPK modeling expert for the Pharmacokinetics, Dynamics & Metabolism (PDM) department. The individual partners with PDM portfolio representatives (PRs), scientific leaders, and crossline modelling scientists to address the ADME and PBPK modeling needs of the portfolio. The individual will be the technical expert for the department, while also influencing external scientific and regulatory practices through publication and other interactions.ROLE RESPONSIBILITIESApply technical and functional PDM expertise to direct or undertake physiologically-based pharmacokinetic (PBPK) modeling strategies, which support and achieve project goals from idea to proof-of-concept through drug registration (including NDA and global submissions), and post-market.Working across global lines with modeling and simulation scientists (e.g., Clinical Pharmacology, Pharmaceutical Sciences), taking scientific leadership for integrating predictions of drug ADME (absorption, distribution, metabolism, and elimination) as well as drug-drug interaction risk assessment.Contribute to authoring, review, and approval of modeling related research reports, nonclinical ADME summaries, and abstracts/manuscripts for internal or external publication. Present data internally and externally in meetings and conference proceedings.Proactively establish and grow effective partnerships externally as well as internally across multiple disciplines (e.g., Clinical Pharmacology, Pharmaceutical Sciences, Medicinal Chemistry, Computational Sciences, High Throughput Screening) to advance scientific innovation in the realm of ADME/PBPK modeling.Keep abreast of scientific/technological developments by participating in scientific meetings/seminars and through regular scientific review.Ensure adequacy, timeliness, and high quality of execution of modeling to meet scientific and regulatory requirements of the U.S. FDA, and Drug Regulatory Agencies worldwide.Mentor scientists in pharmacokinetic data analysis (e.g., noncompartmental analysis) and PBPK modeling.BASIC QUALIFICATIONSMS or PhD level education (or BS with 5 or more years) in a relevant field with industry experience in the scientific field.Experience working in matrix teams within and across technical/research line organizations, a collaborative problem solver.Strong leadership and interpersonal skills as well as a track record of enthusiasm to deliver results in a fast-paced environment.Highly effective written, presentation and verbal communication skills are essential.Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) and hands-on experience establishing IVIVE, computational ADME predictions, and data visualization tools.PREFERRED QUALIFICATIONSHands-on experience with ADME, PK, and physiologically-based (PBPK) modeling using tools such as Simcyp, Phoenix WinNonlin, Berkeley Madonna, NONMEM, R, and/or GastroPlus.Broad understanding of ADME and in vitro drug metabolizing enzyme and transporter assays. Ability to integrate data from multiple sources into a rational understanding of drug disposition.PHYSICAL/MENTAL REQUIREMENTSAbility to perform complex mathematical calculations and its application in PK and PBPK data modeling. High-level integration of complex data in analyses.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSRegulatory responses could be time-sensitive, which occasionally requires working extended hours in the evenings or on weekends. Periodic travel will be required to other Pfizer sites (e.g., Cambridge, MA; La Jolla, CA) or to attend and present at scientific conferences.Additional Information:Eligible for Employee ReferralLast Day to Apply: October 13, 2024
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We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.Senior Scientist (R04) – ADME/PBPK ModelingThe individual will be the ADME and PBPK modeling expert for the Pharmacokinetics, Dynamics & Metabolism (PDM) department. The individual partners with PDM portfolio representatives (PRs), scientific leaders, and crossline modelling scientists to address the ADME and PBPK modeling needs of the portfolio. The individual will be the technical expert for the department, while also influencing external scientific and regulatory practices through publication and other interactions.ROLE RESPONSIBILITIESApply technical and functional PDM expertise to direct or undertake physiologically-based pharmacokinetic (PBPK) modeling strategies, which support and achieve project goals from idea to proof-of-concept through drug registration (including NDA and global submissions), and post-market.Working across global lines with modeling and simulation scientists (e.g., Clinical Pharmacology, Pharmaceutical Sciences), taking scientific leadership for integrating predictions of drug ADME (absorption, distribution, metabolism, and elimination) as well as drug-drug interaction risk assessment.Contribute to authoring, review, and approval of modeling related research reports, nonclinical ADME summaries, and abstracts/manuscripts for internal or external publication. Present data internally and externally in meetings and conference proceedings.Proactively establish and grow effective partnerships externally as well as internally across multiple disciplines (e.g., Clinical Pharmacology, Pharmaceutical Sciences, Medicinal Chemistry, Computational Sciences, High Throughput Screening) to advance scientific innovation in the realm of ADME/PBPK modeling.Keep abreast of scientific/technological developments by participating in scientific meetings/seminars and through regular scientific review.Ensure adequacy, timeliness, and high quality of execution of modeling to meet scientific and regulatory requirements of the U.S. FDA, and Drug Regulatory Agencies worldwide.Mentor scientists in pharmacokinetic data analysis (e.g., noncompartmental analysis) and PBPK modeling.BASIC QUALIFICATIONSMS or PhD level education (or BS with 5 or more years) in a relevant field with industry experience in the scientific field.Experience working in matrix teams within and across technical/research line organizations, a collaborative problem solver.Strong leadership and interpersonal skills as well as a track record of enthusiasm to deliver results in a fast-paced environment.Highly effective written, presentation and verbal communication skills are essential.Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) and hands-on experience establishing IVIVE, computational ADME predictions, and data visualization tools.PREFERRED QUALIFICATIONSHands-on experience with ADME, PK, and physiologically-based (PBPK) modeling using tools such as Simcyp, Phoenix WinNonlin, Berkeley Madonna, NONMEM, R, and/or GastroPlus.Broad understanding of ADME and in vitro drug metabolizing enzyme and transporter assays. Ability to integrate data from multiple sources into a rational understanding of drug disposition.PHYSICAL/MENTAL REQUIREMENTSAbility to perform complex mathematical calculations and its application in PK and PBPK data modeling. High-level integration of complex data in analyses.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSRegulatory responses could be time-sensitive, which occasionally requires working extended hours in the evenings or on weekends. Periodic travel will be required to other Pfizer sites (e.g., Cambridge, MA; La Jolla, CA) or to attend and present at scientific conferences.Additional Information:Eligible for Employee ReferralLast Day to Apply: October 13, 2024
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