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Director, Clinical Pharmacology
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- The clinical pharmacologist will be responsible and accountable for designing clinical pharmacology programs and studies, performing PK and PKPD data analysis, supporting clinical dose selection and authoring summary and regulatory submission documents.
- The clinical pharmacologist will work in collaboration with various stakeholders in a cross-function team environment and provide oversight to external vendors.
- Apply model-based drug development strategy to support clinical dose and dosing regimen selection, facilitate clinical study design and support regulatory submissions
- Author regulatory summary documents, such as briefing documents, IND, NDA, etc., and provide responses to world-wide regulatory authorities for the clinical pharmacology related inquiries
- Provide oversight to external vendors for pharmacometrics, modeling and simulation and DMPK related studies
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