• Developing and executing clinical pharmacology strategies for small molecules and biologics assets • Providing clinical pharmacology expertise in characterizing pharmacokinetics and absorption, distribution, elimination profiles • Justifying dose selection • Assessing drug/food interaction potential • Characterizing QT prolongation potential • Planning and reviewing study designs & analysis plans • Analyzing & interpreting pharmacokinetic and pharmacodynamic data • Developing clinical pharmacology study designs and collaborating with CROs and Clinical Operations • Contributing to the design and analysis of PK data from patient clinical studies • Performing population PK (PPK) analyses • Conducting exposure–response (ER) analyses • Analyzing, interpreting, summarizing and presenting data to internal project teams and to senior management • Assisting in authoring relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions