Senior Director of Medical Affairs, Rare Disease

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.

Job Purpose 
The Senior Director of Medical Affairs, Rare Disease provides exceptional medical leadership for the creation and implementation of medical affairs strategies, plans and tactics for the Rare Disease current products and pipeline portfolio for the North America region, in alignment with Global Medical Affairs and corporate strategy.

Areas of responsibility include:

• Providing subject matter expertise, study design and review; data analysis and interpretation; publications and scientific presentations; medical content development and review; medical education and training; medical information; scientific exchange and collaboration;
• Building strategic medical relationships and partnerships with Key Opinion Leaders, academic and medical institutions, Professional associations and community networks, in collaboration with Medical Scientific Liaisons.
• Serving as the principal contact with internal stakeholders, representing Medical Affairs on internal cross-functional and global teams
• Ensuring that the patient is in the center of all activities, upholding the Kyowa Kirin core values of Commitment to Life, Innovation, Integrity and Teamwork/Wa.

Key Responsibilities:

• Develop and implement US Rare Disease Medical Affairs Strategy and tactical plans aligned with US and global strategic imperatives and in collaboration with internal stakeholders  
• Engage with external partners and stakeholders, including Key Opinion Leaders, Professional associations, community networks and patient advocacy groups to innovate and refine medical affairs strategies, in collaboration with Medical Scientific Liaisons
• Represent US Medical Affairs on cross-functional internal teams and internal review committees (MRC and PRC)
• Direct, design and coordinate medical affairs data generation activities
• Lead the development and implementation of strategic and tactical publication plans
• Support Medical Affairs training function in the development and delivery of the Rare Disease medical affairs training plan, materials, and certifications, and support commercial training activities
• Direct development and dissemination of medical information materials and vendor training including medical information letters and FAQ documents
• Provide Medical Affairs support and input into launch readiness activities including labeling, life cycle management, and other early commercialization initiatives for late stage Rare Disease pipeline products.
• Prepare, manage, process and reporting for budgets for assigned products,
• Oversee vendor-related activities (selection, contracting, onboarding, day-to-day operation, performance evaluation and improvement).
• Coach, manage and support team members; actively manage talent and career development
• Ensure adherence to all applicable SOPs, policies, processes, and compliance guidelines and uphold the highest standards of compliance, ethics and safety.
• Foster a culture of diversity and inclusion, patient-centricity and commitment to Kyowa Kirin core values

Position Requirements:

• Advanced degree in Health Sciences or related fields (MD, PhD, PharmD). 
• Rare Disease experience preferred.
• Minimum of 8+ years of relevant industry experience
• Successful track record of overseeing product launches and lifecycle management