Senior Director, Health Economics & Outcomes Research

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.

The Senior Director of Health Economics & Outcomes Research (HEOR) is a key strategic leader within the Medical Affairs function. In collaboration with the clinical development functions, regulatory, pharmacovigilance, corporate strategy and product development Commercial, Market Access, and other members in Medical Affairs, the Senior Director will lead the HEOR team to develop the HEOR strategy and real-world evidence (RWE) generation plan and to execute tactics to support product development, regulatory approval, and commercialization (pricing and reimbursement, market access, publication/communication) of Kyowa Kirin products. The Senior Director, HEOR is responsible for the strategic planning and implementation of the HEOR and RWE plans to support R&D pipelines and launched products in CNS, rare bone disease, oncology, and immunology.

• Build the HEOR capabilities to support product development and commercialization for all Kyowa Kirin products.
• Lead the HEOR departmental activities and manage the HEOR team.
• Serve as the HEOR expert in cross-functional meetings (e.g., clinical development, life cycle management, data generation).
• Maintain close working relationships with key stakeholders, including Clinical Development, Commercial, Market Access, Global Medical Affairs, and Regulatory Affairs.
• Develop and execute HE&OR strategies and real-world evidence (RWE) generation plans that are aligned with the clinical development/medical objectives and commercial/brand strategies.
• Provide strategic insights and inputs to global clinical development.
• Lead patient-reported outcomes (PRO) activities to support label claims, and the development of economic (cost-effectiveness and budget impact) models and AMCP/global value dossier to support the pricing and reimbursement requirements of payer and health technology assessment (HTA) agencies globally.
• Generate high-quality and relevant HEOR data that demonstrate the clinical, economic, and humanistic value of Kyowa Kirin’s products that are meaningful to external stakeholders (patients, physicians, and payers)
• Monitor the development of research methodologies, clinical practice and professional guidelines, and health policies for targeted and optimal conduct of HEOR research and evaluations
• Collaborate with international medical experts and publish scientific data in peer-reviewed journals and international conferences
• Represent Kyowa Kirin in key external HEOR-related meetings/working groups

Education

• Ph.D. (preferred) or equivalent degree in appropriate field (health economics, pharmacoeconomics, outcomes research, public health, health services research. 

Experience

• 10-15 years of experience in the biopharmaceutical industry is required. 
• Advanced knowledge and experience in conducting health economics, health services research studies, real world studies, and the evaluation of health care interventions.
• Demonstrated strategic thinking skills, strong business acumen, and excellent process and management skills. Superior strategic/tactical planning experience within a pharmaceutical environment is required.  Comprehensive knowledge of the US payer environment and evidence needs to support market access.
• Ability to lead and influence teams to facilitate effective decision-making. In addition, function effectively as a member of cross-functional project teams. 
• Extensive experience in the process of drug development and a strong understanding of regulatory compliance. 
• Demonstrated track record of peer-reviewed scientific publications. 
• Experience of phase II-III clinical development, product launch, and customer-focused HEOR tool development.
• PRO development and label support experience is highly desirable.

Technical Skills

• Proficient in MS Office Suite.

Non-Technical Skills

• Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly.
• Strong interpersonal and communication skills.
• Strong work ethic is required.
• Detail oriented and excellent follow through.
• Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment.
• Has a passion for personal learning and development to be able to grow with the company.
• Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Demands:

• Normal office environment with prolonged sitting and extensive computer work

Working Conditions:

• Requires up to 15% domestic and international travel

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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