
Senior Research Investigator, PBPK
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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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The Translational Medicine & Clinical Pharmacology (TMCP) Department advances scientific discoveries into clinical therapies, by integrating translation biomarkers, clinical pharmacology, and mechanistic modeling approaches, to optimize drug discovery and development and personalized medicine through close collaboration within R&D. Quantitative Pharmacology and Data Analytics (QPDA) is responsible for the Clinical Pharmacology characterization for small and large molecule assets across all therapeutic areas beginning with the entry in humans through registration and after commercial launch. The responsibilities encompass conducting mechanistic model-based Population PK and exposure-response (ER) analysis to drive dose selection, utilizing quantitative system pharmacology (QSP) and physiologically based pharmacokinetic modeling (PBPK) in to characterize PK/PD, DDI liabilities, implications for special populations, understanding the effects of formulation changes, as well as informing other critical drug development questions to influence company decisions. Furthermore, QPDA is responsible for representing mechanistic modeling at health authority interactions and compiling technical documents that are critical for worldwide submissions.
Senior Research Investigator, PBPK
The scientist in this role will join an established Physiologically Based Pharmacokinetic (PBPK) modeling team with demonstrated and growing impact across the pipeline. PBPK modeling has become an important component of drug discovery and development. PBPK models are used to characterize the drug absorption, distribution, metabolism, and excretion (ADME) properties based on calibration to non-clinical and clinical data. This enables extrapolation and generation of hypotheses to inform clinical development. Additional applications include drug-drug interaction (DDI) risk assessment, PK and dose predictions in humans and special populations, prediction of target tissue concentrations, formulation optimization, and early differentiation between lead and backup molecules. PBPK models are often extended to provide projections of target engagement, and pharmacodynamics have been incorporated. Our QSP&PBPK team has established expertise, impact, tools, a strong intellectual environment, and capable colleagues. The individual in this role will take on a variety of projects across therapeutics areas as well as preclinical and clinical development.
An individual is being sought at the Senior Research Investigator level and the site location is Princeton, NJ working a hybrid work schedule.
Responsibilities:
- Provide leadership to and collaboration with multidisciplinary project teams to develop and apply PBPK models
- Demonstrate high proficiency in the development and application of PBPK models to address drug discovery and development questions
- Partner with external groups to accelerate the internal PBPK efforts in key disease areas
- Independently provide expert support to project teams to design, execute and interpret clinical pharmacology studies
- Coordinate with QSP&PBPK methods group on new methodologies for innovative PBPK model development and application
- Network with stakeholders in non-clinical DMPK, biotransformation, and pharmaceutical development to identify and interpret experiments critical for model development and refinement
- Align PBPK model deliverables with clinical pharmacology, pre-clinical, and clinical development plans as appropriate
- Begin to learn how to align application area PBPK strategy with organizational priorities
- Contribute to the standards of practice within the department
- Participate and contribute to departmental and research initiatives
- Serve as a subject matter expert to both internal colleagues and the external scientific DMPK/CPPDB community
- Stay informed with emerging literature and science in the DMPK and PBPK fields
- Establish and maintain effective collaborations with stakeholders in other functional areas
- Build and maintain a personal track record of publication in the area of PBPK
- Maintain an active relationship with colleagues in Clinical Pharmacology, Pharmacometrics, Disposition & Bioanalysis at the project level as well as in the advancement of Pharmacometrics
Position requirements:
- Ph.D. in pharmaceutics, clinical pharmacology, engineering, toxicology or a related field
- For Sr. Research Investigator level, in addition to the Ph.D., 2+ years of post-PhD pharmaceutical industry experience in applying PBPK modeling
- For. Research Investigator level, in addition to the Ph.D., 0-2 years of post-PhD pharmaceutical industry experience in applying PBPK modeling
- Experience within pharmaceutical industry or pharmaceutical consulting is desired (academic post-doctoral or faculty may be a consideration depending on the totality of prior experience)
- Excellent understanding of the theory and principles in pharmacokinetics and pharmacodynamics, drug metabolism and transporters
- Understanding of the theory, principles and statistical aspects of mathematical modeling and simulation
- Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop PBPK models
- Ability to communicate internally and externally on topics related to Clinical Pharmacology and PBPK is required
- Ability to keep up to date with and propose the implementation of scientific and technological developments in the area of PBPK
- Experience with general programming and data analysis tools/languages such as MATLAB, R, Spotfire, etc, is desirable
- Experience developing bespoke models in SimBiology is a plus
- Desire to interact as a modeling and simulation expert with matrix project teams working closely with experts from different functional areas (pre-clinical and clinical)
- Knowledge of current practices and issues in pharmaceutical R&D in disciplines such as clinical pharmacology
- Demonstrated leadership and publication in PBPK
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Uniquely Interesting Work, Life-changing Careers
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On-site Protocol
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