Associate Director/Director Quantitative Clinical Pharmacology
Introduction
We are looking for an experienced Associate Director/Director Quantitative Clinical Pharmacology to join our team. The successful candidate will be responsible for developing and implementing clinical pharmacology strategies, designing and conducting clinical pharmacology studies, providing support for regulatory submissions, and hands on pharmacometric modeling. This role will require someone with strong communication and leadership skills, as well as a deep understanding of drug development and pharmacokinetics.
Responsibilities
* Develop and implement clinical pharmacology strategies in support of drug development programs
* Design and conduct clinical pharmacology studies to support drug development
* Provide support for regulatory submissions, including authoring clinical pharmacology sections of regulatory documents
* Provide input into the design of clinical studies, including pharmacokinetic and pharmacodynamic assessments
* Analyze and interpret clinical pharmacology data
* Collaborate with cross-functional teams to ensure clinical pharmacology objectives are met
* Manage external vendors and consultants as needed
* Stay up-to-date with the latest developments in clinical pharmacology
Skills
* Deep understanding of drug development and pharmacokinetics
* Experience designing and conducting clinical pharmacology studies
* Experience providing support for regulatory submissions
* Experience modelng, analyzing and interpreting clinical pharmacology data using NONMEM, R, etc.
* Experience collaborating with cross-functional teams
* Experience managing external vendors and consultants
