Associate Director, Clinical Pharmacology and Pharmacometrics

Role Summary

Associate Director, Clinical Pharmacology and Pharmacometrics at Bristol Myers Squibb. Responsible for pharmacology and pharmacometric support across the clinical development lifecycle, leading design and analyses of clinical pharmacology studies and contributing to phase 2/3 design and regulatory submissions. Located in Lawrenceville, New Jersey with hybrid work expectations.

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 manage data analysis, interpretation, and reporting
• Demonstrate 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; serve as Clinical Pharmacology subject matter expert

Qualifications

• Advanced Degree in related field (MS, Ph.D. or PharmD)
• For Associate Director with Ph.D.: approximately 5+ years of experience with progression in clinical pharmacology and pharmacometrics; For MS degree: 10 years of experience with progression
• Demonstrated ability to work in a dynamic team-oriented environment
• Experience leading a Clinical Pharmacology team (required for Director level)
• Expertise in general drug development
• Expertise in small molecule and/or biologic drug property characterization
• Demonstrated stakeholder management with strong influence/leadership
• Hands-on Pharmacometrics experience 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.)
• Ability to work hybrid hours in office 50% of time per week in Princeton BMS office

Skills

• Clinical pharmacology and pharmacometrics subject matter expertise
• Pharmacokinetics, pharmacodynamics, and model-informed drug development
• Cross-functional collaboration and stakeholder management
• Data analysis, interpretation, and visualization
• Regulatory submission support
• Programming and modeling tools

Education

• Advanced degree as listed in Qualifications (MS, PhD, or PharmD)

Additional Requirements

• Hybrid work arrangement with 50% in-office presence at the Princeton, NJ area