Associate Director, Clinical Pharmacology and Pharmacometrics
Bristol Myers Squibb
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Role Summary
Associate Director, Clinical Pharmacology and Pharmacometrics
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
- Ability to work hybrid work hours in office 50% of the time per week located in Princeton BMS office
Qualifications
- Advanced Degree in related field (MS, Ph.D. or PharmD)
- For Associate Director with Ph.D. approximately 5+ years of experience with demonstrated progression in clinical pharmacology and pharmacometrics. For M.S. Degree, 10 years of experience with demonstrated progression in clinical pharmacology and pharmacometrics
- Demonstrated ability to work in a dynamic team-oriented environment
- Experience leading a Clinical Pharmacology team is required for the Director level position
- Expertise in general drug development
- Expertise in small molecule and/or biologic drug property characterization
- Demonstrated stakeholder management with strong influence/leadership
- Hands on and demonstrated Pharmacometrics experience required including exposure-response modeling
- Quantitative data analysis, POP PK/PD, and data visualization skills
- Programming experience (e.g., NONMEM, Phoenix NLME, Monolix, R, WinNonlin, SAS, S-plus, etc.)
Education
Skills
- Pharmacology and pharmacometrics expertise across development stages
- Model-informed drug development (MIDD) and PK/PD modeling
- Data analysis, interpretation, and reporting of clinical pharmacology studies
- Cross-functional collaboration and stakeholder engagement
- Regulatory submission support
- Programming for pharmacometrics and data visualization