cartermackay.com Director, Clinical Pharmacology—CA bay area
- Provide expert guidance on all aspects of clinical and non-clinical pharmacokinetics and clinical pharmacology
- Generate PK models and PK/PD models
- Design human PK, ADME and DDI studies and write the protocol sections related to these study components.
- Design non-clinical ADME studies
- Interact with regulatory agencies on topics related to pharmacokinetics and clinical pharmacodynamics
- Write appropriate sections of regulatory submissions
- Perform the analysis of pharmacokinetic and pharmacodynamic data for all clinical studies and provide analyses of data including separate PK or PK/PD reports as applicable, and the results, discussion and conclusion sections of the study reports.
- Perform the analysis of pharmacokinetic data for non-clinical studies, provide data analyses, write the appropriate sections of study reports as applicable.
- Serve as a core or ad-hoc member of project teams as required
- Engage and manage PK consultants if required
To apply for this job email your details to firstname.lastname@example.org