• Full Time
  • Anywhere

CarterMackay Director/Sr. Director Clinical Pharmacology and DMPK

 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

To apply for this job email your details to broseberry@cartermackay.com

CARTERMACKAY

400 Crown Colony Drive, Suite 600

 Quincy, MA 02169

T: 617-689-0029 • F: 617-689-3044

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