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.
- 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.