Job Description 

• Responsible for protocol development, oversight of sample handling/processing, and data analysis/interpretation for Nonclinical and Clinical Pharmacokinetics and Drug Metabolism studies
• Responsible for nonclinical PK/TK/PD analyses; clinical PK, PK/PD, and population PK analyses as well as Modeling and Simulation of clinical dose, schedule, and sequence of drug combinations
• Work with Regulatory Affairs/Publishing Preferred Provider CRO’s to author, manage and coordinate all aspects of Nonclinical and Clinical Pharmacokinetics and Drug Metabolism sections for IND/CTA submissions
• Work with Development Project Teams as well as the Head of Clinical Development to assess and recommend human doses/regimens as well as the potential drug-drug interactions in ongoing or planned clinical trials
• Discovery/Development Project Team member
• Manage DMPK/Clinical Pharmacology -related program-specific plans/timelines

 Minimum Requirements

The successful candidate will have a proven track record in the above areas and be able to work in a fast-paced, dynamic environment. Minimum requirement includes:

• PhD or  Pharm D, in Pharmacokinetics, Pharmacology, or related discipline with 10+ years’ experience as a DMPK/Clinical Pharmacologist team member on various drug development programs
• Comprehensive understanding and practical application of DMPK/Clinical Pharmacology concepts in drug development
• Experience in managing nonclinical and clinical bioanalysis and other relevant Development DMPK outsourcing activities
• Experience in Modeling and Simulation of nonclinical and clinical data
• Ability to grasp complex concepts and effectively communicate with worldwide Health Authorities
• Exceptional project management and people skills