Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in-human testing through all phases of clinical development
Lead clinical pharmacology or pharmacometric activities on project teams
Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports
Contribute to the design and analysis of PK data from patient clinical studies
Conduct hands-on clinical PK, population PK and exposure-response data analysis
Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions

Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacometrics, Biomedical Engineering or related discipline with 5+ years of relevant experience
Proficiency with NONMEM/Monolix and R/S-Plus preferred
A Ph.D. or equivalent with at least four years of industry and/or related post-doctoral experience is preferred
Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings
Hands-on modeling & simulation experience and/or publications are essential
Prior experience in AI/automation of clinical pharmacology and pharmacometrics preferred.

Director, Clinical Pharmacology, Pharmacometrics

Key skills