Location: MA Or NJ
Client: Major Pharmaceutical Company
Full Time, Direct Hire
The team is looking for an experienced clinical pharmacologist to join their Pharmacokinetics, Dynamics & Metabolism department as the Director of PKDM. You will serve as the clinical PK/PD expert participating in multidisciplinary teams for clinical phase development projects in a range of therapeutic areas. This position is based out of MA OR NJ.
Join their team to shape the future of medicine and accelerate drug discovery and development.
Key Responsibilities:
- Formulate drug development questions and create quantitative pharmacology strategies for programs in all stages of development, ranging from first in human dosing through life cycle management
- Serve as a PKDM representative on multidisciplinary project teams, advancing drug candidates from IND to successful approval.
- Design, plan, and oversee clinical studies, including PK/PD analysis, interpretation, and reporting.
- Apply quantitative modeling and simulation skills for dose selection and addressing complex issues in drug development.
- Contribute to clinical pharmacology sections of regulatory documents and respond to regulatory inquiries.
Qualifications:
- Extensive experience in clinical development including PK/PD concepts and modeling & simulation strategies to support drug development
- Education: Ph.D. with or without post-doctoral experience plus at least twelve (12) years of relevant experience
- Demonstrated experience in interacting with and influencing regulatory agencies worldwide such as FDA, EMA and PMDA.
- Ability to work collaboratively in multidisciplinary teams
Join my client and make a difference in the lives of patients and their families! Apply to learn more about this ground breaking opportunity!
