Looking to advance in your leadership and contributions to drug development? Our client is a well capitalized, 150 person, full pipeline, small molecule company with room for you to grow personally and professionally. This person will serve as a DMPK project representative to coordinate and lead DMPK activities on programs from lead optimization through IND and into early clinical development. As such, an individual with in-depth knowledge and expertise supporting lead optimization programs (e.g. understanding drug metabolism and biotransformation, assessing DDI potential, CYPs, and Transporters etc.) is essential.

 Key Responsibilities

  • Design studies and implement strategies for metabolic profiling, understanding metabolic liabilities, assessing DDI potential (CYPS and transporters) etc.
  • Develop assays and coordinate DMPK studies either in-house or at CRO’s. 
  • Oversee the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external vendors/academic sites
  • Author high quality Regulatory documents including INDs, CTAs and NDA filings.
  • Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments

  Experience & Education

  • PhD with 7+ years in industry OR BS/MS with 15+ years of experience of relevant industry experience in the field of drug metabolism studies
  • Strong knowledge of drug metabolism and pharmacokinetics principles plus experience applying DMPK concepts and principles to drug discovery and development programs
  • Experience in authoring DMPK sections for IND and other regulatory filing
  • Demonstrated capability to work well in a matrix environment
  • Ability to build strong relationships with peers and cross functionally with partners outside of team to enable higher performance.

A strong medicinal chemistry understanding as well as expertise using high resolution mass spectrometers and software packages to support biotransformation work (TOFs, Q-Traps, Orbitraps etc.) is a plus

To apply for this position, confidentially email us here.