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- The Director, DMPK will report to the Vice President of DMPK and will primarily liaise with our highly dynamic Chemistry, Pharmacology, and Toxicology departments to develop strategies and advance discovery programs to the clinic.
- The individual should have strong scientific training in all areas of DMPK and a demonstrated track record of leading focused DMPK groups in the biotechnology or pharmaceutical industry.
- Manage effective cross-functional collaboration, especially with in vitro/in vivo pharmacology and toxicology and provide guidance in the optimization of drug leads and candidates, in understanding of PK/PD and human dose projections.
- Recommend timing for DM (Human ADME studies) and DDI studies needed to support clinical trials and NDA submissions.
- Be a subject matter expert and educate all disciplines with regards to applications of DMPK principles to drug development.
- Oversee completion of relevant DMPK reports and documents for development candidate nomination and regulatory filings including reports, Investigator Brochures, and INDs (or equivalent).
- Contribute to cross-functional review of all regulatory documents and author and review DMPK sections for relevant regulatory documents e.g. reports, IND, IB, MAA.
- Work with the discovery senior management to recruit scientists and build a team to support the DMPK strategy and drive the discovery engine.
Director, DMPK - San Diego, United States - Crinetics Pharmaceuticals, Inc
