Senior Director, Clinical Science- Nephrology

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary:

The Senior Director, Medical Science, Nephrology is a subject matter expert (SME) Leading the Clinical Science Team and providing expertise in clinical development in the therapy area including content for interactions with regulatory agencies.

Essential Functions:

•    Provide expert strategic and tactical input to product and Therapeutic Area Global Development and Life Cycle management programs

•    Have a very high level, clear and broad perspective on the therapeutic area and be aware of important advances within that area (including competitive intelligence), through relationships with KOLs, the scientific literature and attendance at critical meetings. Be able to communicate this perspective appropriately

•    Lead Clinical Science input to regulatory meetings and at scientific committees and advisory boards

•    Represent the product and indication area internally and externally as the clinical science expert

•    Provide expert Clinical Science leadership as the key link to Translational Science function and Clinical Pharmacology and as the Clinical Science representative where necessary

•    Take the Clinical Science lead for development of product publication strategy, plus the medical scientific content and quality of publication team outputs

•    Present on behalf of projects / Kyowa Kirin as appropriate

•    Organize and appraise critical review of competitor intelligence and act accordingly

Requirements:

Education
MD, combined MD, PhD or relevant clinical or biomedical Ph.D.  A Science, pharmacy, nursing or MSc degree with significant relevant R&D experience may be acceptable

Experience
At least 5 years experience within the pharmaceutical industry and therapeutic area knowledge in the therapeutic area.  Candidates should also have medical training, such as by completing an internship and residency program after medical school, and they should have board certification and a license to work in a medical setting. 

•    Must be able to demonstrate a strong understanding of clinical development 

•    Significant experience working with regulatory agencies, preparing regulatory documents

•    A high level understanding of more than one function and how they contribute to drug development and ultimately to achieving the objectives of the business
 
•    Extensive knowledge of the workings of and challenges faced by the pharmaceutical industry

•    Extensive leadership experience and coaching / mentoring ability

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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