Looking for a dynamic organization that is well run, fun to work at, and has a transparent, open and respectful company culture? One where you can be appreciated and acknowledged for your contributions and know you are making a difference? Want to be one who builds a team and expand the DMPK function?
The Head of DMPK will lead a team of leaders and should have experience with directing a team of half a dozen or more people. S/he will serve as a DMPK project representative to coordinate and lead all nonclinical DMPK activities on programs from the research through early development phases. As such, having in-depth knowledge and expertise in PK and ADME will be essential. The right candidate will also bring a strategic vision and collaborative mindset to work in conjunction with the Clinical Pharmacology team.
The role will suit a highly motivated individual who has a passion for science, enjoys developing new and innovative technologies, exhibits urgency, and fits well with a growing and energized small-medium size biotech culture.
S/he will also be required to stay current with the latest in technological and regulatory advances in the DMPK arena and demonstrate strong interest and expertise in PK and physicochemical properties modeling techniques.
This role will involve both in-house assay development and implementation, coordination of DMPK activities at CRO’s, and guiding project DMPK activities across multiple phases including lead discovery, lead optimization and regulatory filings.
- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates
- Lead the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external vendors/academic sites
- Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo ADME studies.
- Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals
- Author high quality Regulatory documents including INDs, CTAs and NDA filings
- Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
- Participate in the preparation of abstracts and manuscripts for publication
MS degree or Ph.D. (Strongly Preferred) in Chemistry, Biochemistry, or similar scientific discipline and the following experience:
- 10+ years in a biopharma setting
- Knowledge of drug metabolism and pharmacokinetics principles
- Experience in applying DMPK concepts and principles to drug discovery and development – Experience in authoring DMPK sections for IND and other regulatory filings
To apply for this position, confidentially email us here.