Director, Clinical Pharmacology

Position Summary

The Director, Clinical Pharmacology is responsible for leading the planning, implementation, and execution of clinical pharmacology strategies across one or more development programs, reporting to the Senior Director, Clinical Pharmacology & Pharmacometrics.

Key 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
• Lead and participate in departmental initiatives and represent CP&P on cross-functional initiatives / workstreams / taskforces
• Work with Business Development teams and provide critical expertise to assess external acquisitions

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