About the job
Kyowa Kirin is an innovative and rapidly expanding global specialty pharmaceutical company dedicated to harnessing cutting-edge biotechnologies to develop and provide breakthrough treatments in four key therapeutic areas: bone and mineral disorders, intractable hematologic conditions, hematology oncology, and rare diseases. Originating from Japan, we strive to transform scientific advancements into meaningful therapies by addressing unmet medical needs from the initial stages of drug discovery through to product development and commercialization. Our North American headquarters is located in Princeton, NJ, with additional offices in California, North Carolina, and Mississauga, Ontario.
Summary:
The Director of Clinical Pharmacology will act as the clinical pharmacology subject matter expert (SME) within internal project teams, overseeing the pharmacological profiling of small molecules and biologics in therapeutic domains such as oncology, nephrology, and immunology. This role entails the design and execution of clinical pharmacology strategies utilizing both traditional and model-informed drug development (MIDD) methodologies aimed at expediting drug development processes. The Director will be critical in planning, conducting, and interpreting clinical pharmacology studies throughout the early, full, and lifecycle phases of clinical development. Responsibilities also include contributing to clinical development plans, protocols, and study reports, as well as preparing regulatory submission components for clinical pharmacology and representing the department in discussions with health authorities. The position will also involve enhancing processes to optimize the management and execution of Clinical Pharmacology activities.

