Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary: The Director, Clinical Science (non-hemato-oncology) is a vital position in our growing global organization. , IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from the clinical perspective, diving deeply into the science of her/his assigned program(s), and perform the role of a subject matter expert for the program(s).

, BB, IND), study protocols, and clinical development plans for new and/or launched products, including lifecycle management. He/she will be responsible for establishing and maintaining KOL relationships.

Requirements

and standards throughout the course of clinical trials. • Work closely with cross-functional teams, including Regulatory, Marketing, and Quality to support clinical trial design and execution, regulatory submissions, and launch-related activities. • Provide input from the clinical perspective to the formulation of Target Product Profiles.

g. AE assessment, as needed. • Create and maintain good relationships with clinical investigators and relevant Key Opinion Leaders; identify physicians with potential to serve as strong investigators for clinical studies • Attend relevant scientific meetings to strengthen competency in assigned field(s) and to gain awareness of research activities underway and activities of competitors • Serve as an author and lead in the preparation of review articles and conference presentations, relating to assigned clinical trial(s) • Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).

• Foster and contribute to collaborative environment that seeks to encourage innovation, strengthen scientific understanding among team members, and enhance professional development for all. • Perform other duties, as required.

: Education MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R D experience may also be considered.