Director, Clinical Pharmacology
Bristol Myers Squibb EU Policy · Princeton, NJ · 3 wk ago
HybridResearch$226k–$274k/yrFull-time
About the role
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 with the resources to pursue their goals, both at work and in their personal lives.
Responsibilities
- Supervise and/or mentor other CP&P leads as appropriate
- Independently contribute to compound development across various development phases
- Represent Clinical Pharmacology at asset teams at governance based on proficiency
- Provide input to Phase 2/3 clinical study design and registrational strategy
- Accountable for Clinical Pharmacology and Pharmacometrics 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, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert
- Participate in interactions with health authorities; serve as Clinical Pharmacology subject matter expert
Qualifications & Experience
- MS, PhD or PharmD in relevant field or a PharmD with clinical pharmacology research fellowship
- Approximately 7+ years’ experience with demonstrated progression in Clinical Pharmacology and Pharmacometrics, including expertise in the general drug development process and in small molecule and/or biologic drug property characterization
- In-depth knowledge of current practices and issues in Clinical Pharmacology and Pharmacometrics
- Strong written and oral communication skills necessary to report on and deliver scientific presentations
- Demonstrate the ability to work in a dynamic team-oriented environment
- Manage and provide mentorship and guidance to staff and CP&P function
- Independently serve as the CP&P lead for one or more assets in the BMS drug development program
- Demonstrated stakeholder management with strong influence/leadership
- Programming experience is highly desired (e.g., NONMEM, R, and WinNonlin. SAS, Splus, etc.)
- Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired