Position Code: 21050-19B
The successful candidate will support Gossamer Bio’s drug discovery and early development efforts as a key member of the DMPK team. The candidate 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.
- Study design and implementation of strategies for metabolic profiling, understanding metabolic liabilities, assessing DDI potential (CYPS and transporters) etc.
- Assay development and coordinate of DMPK studies either in house or at CRO’s.
- Responsible for 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 or BS/MS with 15+ years of experience of relevant industry experience in the field of drug metabolism studies
- The candidate must have a strong knowledge of drug metabolism and pharmacokinetics principles and experience in applying DMPK concepts and principles to drug discovery and development programs
- 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.
- Experience in authoring DMPK sections for IND and other regulatory filings
- 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.
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected].