Remote Nonclinical PK ADME Associate Director

Location: Texas

Compensation: To Be Discussed

Staff Reviewed: Wed, Jul 07, 2021

This job expires in: 11 days

Job Category: Sales

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Doctorate

Job Summary

A medical research and drug development company is seeking a Remote Nonclinical PK ADME Associate Director.

Core Responsibilities Include:

  • Leading the effort and manage all nonclinical PK/ADME studies executed at external CROs to support the progress of the company's development programs
  • Assisting in NCE compound selection and preparation of IND-enabling nonclinical data packages that satisfy global regulatory expectations and requirements
  • Participating in the planning, design, oversight, analysis, and reporting of nonclinical DMPK studies

Position Requirements Include:

  • Being an experienced professional with a minimum of 9+ years of highly relevant pharmaceutical/biotechnology experience
  • Having familiarity with global regulatory affairs activities, including recent hands-on experience contributing to relevant regulatory submissions
  • Having knowledge and understanding of applicable global regulatory guidance documents pertaining to PK/ADME in drug development
  • Having good expertise/knowledge of Phoenix WinNonlin software and use to generate PK/ADME data and interpretation
  • Having experience in in-vitro/in-vivo assays to characterize the metabolism of small molecule drugs
  • Having excellent technical writing and communications skills with strong background in oral small molecule pharmaceutical development and regulatory writing

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