KEY RESPONSIBILITIES:
1, Serves as the Clinical Pharmacology representative on drug development and clinical sub-teams and provides clinical pharmacology expertise and leadership to projects.
2, Plans and directs clinical pharmacology components of clinical programs (including clinical development plan and medicine plan) and studies (including design, synopsis preparation and reporting).
3, Works with multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies.
4, Responsible (with Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients.
5, Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed-upon best practices (i.e. model-informed drug development).
6, Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
7, Responsible for appropriate summarization and interpretation of results of pharmacokinetic/pharmacodynamic (PK-PD) analyses with respect to their impact on development and clinical use of drugs.