Immunology Head, Global 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 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 of Job:

To provide scientific and medical leadership in Kyowa Kirin for Immunology Therapeutic Area (TA), for marketed products and development portfolio, in global medical affairs and be accountable for the planning and delivery of TA Medical Affairs Strategic Plan (eg. evidence generation, scientific communication strategy, external partnerships with experts, academia & patient’s groups) ensuring that goals and priorities are in alignment with business and medical operating model.

To develop and implement the global medical affairs strategic plan for Immunology TA in cross collaboration with internal stakeholders including (but not limited to) regional medical teams, HEOR, Patient Advocacy, Market Access, Commercial and R&D.

To collaborate with and input into R&D to help shape the clinical development plans in Immunology TA, especially for a development product, in order that patients, physicians and payors’ needs are addressed in clinical studies. This also includes regulatory submission and payor reimbursement strategy.

Leadership of medical launch and to ensure excellence in the transition from Phase 3 to peri- and post-launch phase, for a development product.

Essential Functions:

• Develop comprehensive scientific /medical knowledge and technical expertise of the products (Marketed products and development portfolio) profile within Immunology Therapy Area.
• Develop the Global Medical Affairs TA Strategy for Immunology Therapy Area during clinical development, regulatory submission, and subsequent ongoing lifecycle-driven revisions with key responsibilities to include the following:
• Provide early input to the Target Product Profile (TPP) of portfolio compounds.
• Develop and deliver the global integrated evidence generation plan including TA specific needs for Phase 4 studies including Real World Evidence (claims database, registries etc.). This may include introduction of any proposed pre-authorization Early Access Programme and potential post-marketing requirements.
• Provide medical input to the development of Life Cycle Management strategy for key assets.
• Lead discussion on ongoing lifecycle data generation, including oversight of unsolicited investigator sponsored trial proposals.
• Manage Medical Affairs partnership with ongoing and/or potential alliance partners (for development and commercialization)
• Provide input into labelling process and health authority negotiations to optimize the value of our medicines and to enable good clinical practice.
• Support payer/market access strategy with HEOR and Market Access colleagues.
• Collaborate with the commercial team to develop the brand plan, appropriate commercialization strategy and responsibility for the review / approval of global brand promotional messages
• Ensure consistency of approach between regions (NA/EMEA/APAC/Japan), seeking regional insights and to support their medical needs within the medical strategy
• Support the clinical development organization and lead with publication planning of clinical data (at P2b/3 study phase) in collaboration with Scientific Communication colleagues
• Lead and deliver the global medical strategy (including the global medical launch plan as appropriate) within Kyowa Kirin for products within Immunology TA and to focus on evidence generation gaps, scientific dissemination plan and external partnership. These include the following (but not limited) to:
  • Devel