AssociateDirector,ClinicalPharmacology

**ROLE SUMMARY:** You will join a team of scientists supporting oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for oncology programs. **ROLE RESPONSIBILITIES:** * Represent Clinical Pharmacology on Clinical Sub Team and Development Team. * Participate in the implementation of model-based drug development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase III results. * Provide the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team including plan, design and oversee clinical pharmacology studies with operational assistance from operations colleagues * Serve as an expert on the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol. * Coordinate with Medical Writers (and other team members) in the data review, analysis and reporting of the CP study. Share responsibility with Medical Writer, for overall content and accuracy of study report before forwarding for final sign-off. * Responsible and accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and meta-analysis. * Directs the planning of all relevant PK-PD analyses. Use innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant). * Provide recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in