This position has varying responsibilities in clinical pharmacology, pharmacokinetics and pharmacodynamics which include but are not limited to:

• Assisting in participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goals
• Contribute to the development of clinical pharmacology strategy of programs
• Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA’s, IB’s, etc.)
  • This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.  Planning, preparing and reviewing drug development plans and regulatory filings
• Identifying and managing consultants and vendors supporting clinical pharmacology studies
• Effective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plans
• Work closely with Bioanalytical Scientists, Data Managers, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programs
• 10% to 20% Travel Required

PhD or MD with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis

Strong understanding of clinical pharmacology principles and the drug development process

Good working knowledge of Phoenix and other software for PK/PD analysis

Ability to work both independently and on strong cross functional teams

Demonstrated superior oral and written presentation skills required

Collaborative and flexible in personal interactions at all levels of the company