Vice President, Global Head, Medical Sciences

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.

Lead, manage and represent the GDO Medical Sciences function ensuring excellence in medical and therapeutic area expertise for all aspects of global drug development, including medical advisement to drug discovery and Business Development (BD). Recruit, retain and manage the global group of Medical Scientist ensuring the accomplishment of the team’s objectives as planned, maintaining, or improving timelines, under budget, with effective and efficient use of resources. Partner effectively with key stakeholders, including other GDO Function heads, Global Product Strategy Department (GPSD), and colleagues on Research, Pharmacovigilance and Medical Affairs. Negotiate and resolve Medical Sciences issues with key stakeholders, partnering in efficient way with Project leads and Clinical Scientists.

Contributes to creation and review of Global Clinical Development Plans (CDPs), Global Integrated Development Plans (IDPs) and Global Product Strategy.

• Recruit, develop and retain talented MDs in Medical Sciences. Motivate, develop, and continuously coach direct reports. Manage performance of MDs in their roles as project and study physicians.
• Effectively lead and manage Medical Sciences, including budget, personnel assignments, performance, resource requests, resource prioritization, definition of relevant roles and responsibilities, etc.
• Maintain close and efficient working relationships with key stakeholders, including GPSD, Medical Affairs, BD, PV and other global functions. Maintain good working relationships with all members of GDO leadership team, and senior management in KK North America, KK International KK Asia Pacific and KK Corporate in headquarters Japan. Uphold cultural values of KKC.
• In partnership with global stakeholders, reinforce and continuously improve the process for creation of global development strategy and plans.
• Manage, establish, and improve the strategic approach and process to provide the medical and scientific voice for all programs since very early in research and development, as well as support BD activities providing medical and scientific evaluation from development perspective.
• Ensure Medical and Scientific rational is embedded in all programs and their development plans. Partner with project teams, especially with Project Leader (PL) and Clinical Science Leader (CSL), for the approval of global CDPs and life cycle management by Development Committee (DC), the Research & Development Committee (RDC) and KKC CEO’s Executive Committee (EC).
• Ensure the medical scientists team supports the development of clinical trial protocols, their execution, medical interpretation of study results, medical content of regulatory documents and medical content of internal planning documents. Provide expert medical input and managerial overview as needed.
• Ensure that medical scientists team leads the strategic publication workstream for each project in alignment with the project strategy, coordinating the involvement of different stakeholders such as the key study investigators and other.
• Ensure compliance with Good Clinical Practices (GCPs), ICH, internal Standard Operating Procedures (SOPs), Ethical Guidelines and other relevant corporate, regulatory, or legal requirements.
• Arrange, contribute, manage and lead consultation activities with clinical investigators and external expert consultants as appropriate. Support recruitment of clinical investigators and negotiation of study designs as needed.
• Oversee the establishment and management advisory boards and steering committees for all TAs of interest to KK.
• Facilitate communication between Medical Sciences MDs and scientists in Kyowa Kirin Research (KKR) and KKC in Tokyo (Fuji and Tokyo Research Parks) in the form of presentations, teleconferences or roundtable discussions as indicated. Provide advice on pre-clinical development candidates to research staff at Tokyo and Fuji Research Parks. Facilitate communication with Business Development and Commercial partners from North America/Europe (NAEU) and KKC, particularly during preparation of Development Strategy and alignment of drug development, business development, and commercial plans.
• Serve as member and represent the senior medical opinion on the GDO Leadership Team. Serve as member of key committees like, P