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
