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Clinical Pharmacology and Pharmacometrics Professional
2 months ago
**About Us**
Bristol-Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are a company that is passionate about innovation, urgency, accountability, inclusion, and integrity. Our mission is to deliver innovative medicines that help patients overcome life-threatening diseases.
**Job Summary**
We are seeking a highly skilled Clinical Pharmacology and Pharmacometrics Professional to join our team. As a member of our team, you will be responsible for providing clinical pharmacology and pharmacometrics support for all pipeline assets throughout the clinical development lifecycle. You will work closely with discovery and translational scientists, project leadership, early and late clinical development teams, and commercial colleagues to provide input on clinical pharmacology profiling, dose optimization, formulation bridging, and combination strategies.
**Responsibilities**
• Independently contribute to compound development across various development phases
• Represent Clin Pharm on asset teams and at governance meetings based on proficiency
• Provide input to Phase 2/3 clinical study design and registrational strategy
• Accountable for the Clinical Pharmacology Plan
• Lead design of clinical pharmacology studies and manages data analysis, interpretation, and reporting
• High proficiency in PK, PK/PD, and model-informed drug development (MIDD) principles and analyses
• Collaborate on cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert
• Lead and participate in departmental initiatives and represent CP&P on cross-functional initiatives/workstreams/taskforces
• Participate in interactions with health authorities; serves as Clinical Pharmacology subject matter expert
• Provide critical expertise to Business Development teams to assess external acquisitions
**Requirements**
• Advanced Degree in related field (MS, Ph.D. or PharmD)
• For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated progression clinical pharmacology and Pharmacometrics experience
• For Sr. Research Investigator, with Ph.D. approximately 2+ years experience with demonstrated progression clinical pharmacology and Pharmacometrics
• For Research Investigator, with Ph.D. approximately 0-2 years experience with demonstrated progression clinical pharmacology and Pharmacometrics
• Demonstrated ability to work in a dynamic team-oriented environment
• Expertise in general drug development
• Expertise in small molecule and/or biologic drug property characterization
• Demonstrated stakeholder management with strong influence/leadership
• Quantitative data analysis, POP PK/PD, and data visualization skills
• Programming experience (e.g., NONMEN, Phoenix NLME, Monolix, R, WinNonlin, SAS, Splus etc.)