Associate Director, Clinical Pharmacology

We are seeking a highly motivated and experienced quantitative clinical pharmacologist to join our team as a Clinical Pharmacology Lead. The successful candidate will have a strong background in clinical pharmacology, pharmacokinetics, and modeling, and excellent leadership and communication skills.

Requirements

• Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field
• 6+ years or 10+ years of experience in pharmaceutical industry
• Strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches
• Sound working knowledge of cross-function interfaces and non-clinical and clinical DMPK processes
• Programming experience (e.g., NONMEN, Phoenix NLME, Monolix, R, WinNonlin, SAS, Splus)
• Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology
• Experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents

Benefits

• Actively seeks to foster a culture of diversity, inclusion and belonging
• Proud to have been recognized as an employer of choice by many national organizations
• Has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder