Associate Director, Clinical Pharmacology

Key Responsibilities

• Independently contribute to the development of compounds across various therapeutic areas with some supervision
• Provide input to Phase 2/3 clinical study design and registrational strategy design for the compound with supervision
• 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; serves as Clinical Pharmacology subject matter expert
• Lead or participate in departmental initiatives; may be involved in external initiatives based on proficiency
• Provide expertise based on proficiency to Business Development teams

Qualifications & Experience

• MS, PhD or PharmD in relevant field
• 5+ years’ experience with demonstrated progression in Clinical Pharmacology and Pharmacometrics knowledge, including experience with general drug development process and 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
• Demonstrated ability to work in a dynamic team-oriented environment
• Provide mentorship and guidance to staff and the CP&P function
• Serve as a mentor within the Clinical Pharmacology and Pharmacometrics organization to support the continued growth and development of the team