Senior Vice President Cheif Medical Officer Head, North American Medical Affairs

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 two 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.The Kyowa Kirin North America Chief Medical Officer provides strategic, scientific/medical and operational leadership to maximize the value of our Kyowa Kirin products across all therapeutic areas, supporting KKNA Corporate and Franchise strategies, in alignment with Global Medical Affairs strategy to achieve business objectives and make a profound impact on patients.  They will lead the KKNA Medical Organization, covering the United States and Canada, overseeing all Medical Affairs activities, including developing and executing robust evidence generation plans, building trusted external partnerships, driving innovation in medical engagement and activity impact with health care professionals and Key External Experts (KEE’s), incorporating the voice of the patient, while meeting budget targets and ensuring compliance with legal and regulatory laws and policies in all activities.

The CMO is a strategic partner for the Therapeutic Area Franchises, leading a dynamic team and overseeing medical strategy and operational execution with excellence for marketed products and products in development, in addition to providing expertise in business development initiatives, as required.

The CMO works closely with the Research and Development organizations driving overarching scientific leadership specifically in Hematology/Oncology, Bone Mineral, Rare Disease and Gene & Cell therapies, and in future therapeutic areas that may arise.

As a key member of the North American Executive Committee, the CMO enables superior results for patients through discussions and decisions that focus on execution, developing capabilities, problem-solving and developing people and our culture, while embedding compliance in all activities.

As a key member of the Global Medical Affairs (GMA) Leadership Team, the CMO contributes to the development and execution of the GMA Strategy, maximizing the value of Kyowa Kirin medicines for patients.

The CMO will also be the medical leadership face and voice of Kyowa Kirin North America to various external constituencies, including healthcare professionals and patient organizations.

Key Responsibilities

• Oversee development and execution of Kyowa Kirin North American Medical Affairs strategies for all therapeutic areas, including marketed products, pre-launch products, and Life Cycle Management (LCM), including the generation of relevant clinical and outcomes data to support patient access to Kyowa Kirin products.
• Provide medical input to the Franchise Brand Planning process and the launch readiness planning process.
• Develop and lead North American evidence generation strategies and execution, including Real World Evidence, Health Economics and Outcomes Research, Investigator Initiated Studies, Collaborative Research and Corporate Sponsored non-registrational studies.
• Contribute to the development and execution of Global Medical Affairs Medical Strategy Documents and Evidence Generation plans.
• Drive impactful publications, evidence dissemination and scientific/medical communications
• Incorporate the patient voice and perspectives into medical and corporate plans and deliverables
• Lead the development of strategic partnerships with healthcare professionals, academic medical centers, professional societies and other key external stakeholders.
• Chair Kyowa Kirin North America Medical Affairs governance committees and participate on Global Medical Affairs and other Kyowa Kirin North America governance committees
• Oversee medical review on Medical Review and Promotional Review Committees.
• Build and strengthen capabilities and evolve the organization to meet the challenges of the dynamic healthcare environment
• Ensure compliance with legal and regulatory laws and policies in all activities.
• Support KKNA Medical Affairs to enable sound ethical decision-making

Education

• An MD degree is required for this role.

Position Requirements

• This position requires a minimum of 15 years in pharmaceutic industry with Medical Affairs leadership experience
• In-depth understanding of the US and Canadian healthcare landscape is required.
• Strong command of the drug development process, regulatory environment,