- Conduct PK/PD data analysis using compartmental modeling and non-compartmental approaches.- Apply strategic direction and vision on PK/PD data analysis to support clinical trial designs, compound development plans, and regulatory submissions.- Generate predictive simulations and provide input into trial protocol development.- Provide input into clinical trial SAPs and standalone PK/PD Analysis Plans.- Author and//or review PK/PD documents or reports such as PK Study Reports, ensuring appropriate and accurate interpretation of PK and PK/PD-related endpoints.- Work with regulatory affairs personnel to provide PK/PD data in support of regulatory communications and presentations- Keep current with general requirements and guidelines, as well as with developments in the field.