Principal Scientist - Quantitative Clinical Pharmacology (QCP)

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The scientist will join the Quantitative Clinical Pharmacology group to perform model-based meta-analysis, facilitate model-based drug development and provide broad pharmacometrics strategic leadership.

PositionDescriptionandResponsibilities:

The Clinical Pharmacology & Pharmacometrics (CP&P) department is searching for a scientist with expertise in Pharmacometrics (Pm) and Model-Based Meta-Analysis (MBMA). The scientist will join the Quantitative Clinical Pharmacology (QCP) group to perform MBMA, facilitate model-based drug development and provide broad Pm strategic leadership.

This individual will be responsible for:

• Collaborating with cross-functional team members to help address key program and portfolio level questions
• Developing and implementing Pm/MBMA analysis strategies to address key questions
• Ensuring alignment of the Pm/MBMA strategy with the global clinical development plan
• Reporting and interpretation of Pm/MBMA analysis results
• Contributing to Clinical Pharmacology regulatory submissions (pre- and post-approval)
• Serving as a Pm and MBMA expert to internal colleagues across the organization and to external organizations such as government regulatory agencies.

This position will provide opportunities for internal and external growth and leadership in both Pm and Clinical Pharmacology.

PositionRequirements:

• Ph.D., PharmD, and/or M.D. in biological/medical/pharmaceutical sciences, engineering, or a related field, with 3+ years of experience (industry and/or academia) in Pm analyses (e.g., model-based meta-analysis, population pharmacokinetics, exposure-response and disease progression) using S-PLUS/R and NONMEM, or similar software. Candidates with M.S. degree and significantly more industry experience will also be considered
• Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
• Thorough understanding of the basic principles of pharmacokinetics and pharmacodynamics
• Experience in development and application of model-based meta-analyses is preferred
• Ability to communicate internally and externally on topics related to Clinical Pharmacology, Pharmacometrics and Model-Based Meta-Analysis is preferred
• Ability to keep up-to-date with and propose the implementation of scientific and technological developments in Pharmacometrics
• Extensive hands-on experience with modeling software like NONMEM Monolix, S-PLUS/R, WinBUGS/OpenBUGS, S-ADAPT, SAS, etc.
• Experience with general statistical programming tools/languages such as R, Matlab, SAS, etc.
• Experience supporting clinical development in theCardiovascular Disease, Immunology and/or Fibrosis is preferred
• Knowledge of current practices and issues in clinical pharmacology, bioanalytical, biopharmaceutics, toxicology and regulatory affairs would be a plus