Global Medical Affairs Therapeutic Area Head, Rare Disease
Kyowa Kirin North America · Princeton, New Jersey, United States
Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.
Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.
Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.
We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.
Summary of Job:
The Global Medical Affairs Therapeutic Area Head, Rare Disease, provides strategic scientific and medical leadership for the Rare Disease portfolio within Kyowa Kirin. Reporting to the Global Head of Medical Affairs, the position is a member of the Global Medical Affairs Leadership Team and is accountable for the development and execution of global Medical Affairs strategies and plans across the therapeutic area.
This role is accountable for leading the development and delivery of the Rare Disease Global Medical Affairs Strategic Plans, including evidence generation, scientific communications, publications, external partnerships, and launch readiness, while ensuring alignment with business and franchise priorities. Success requires close collaboration across Franchise, Regional Medical, HEOR, Patient Advocacy, Market Access, Commercial, Legal and Compliance, and Regulatory Affairs, R&D functions to support integrated execution of Medical Affairs strategies.
Strategic medical input is provided to clinical development and regulatory strategies in Rare Disease, incorporating patient, physician, and payer perspectives and supporting health technology assessment (HTA) and payer strategies. The position also provides medical and scientific expertise to Business Development, Regional Medical, and Regional Business teams in the evaluation and prioritization of potential assets, including due diligence and portfolio decisions, and supports the successful execution of partnering activities.
Essential Functions:
Strategic Leadership and Medical Expertise
- Provide comprehensive subject matter expertise, scientific, medical and technical knowledge of products and disease area landscapes for marketed and development portfolio within Rare Disease Therapy Area.
- Significant contributor to Integrated Asset Plans and Integrated Evidence Generation Plans
- Develop and execute the Global Medical Affairs Strategy for the Rare Disease Therapy Area (TA) portfolio, in alignment with business and franchise priorities, and the Integrated Asset Plan
- Ensure consistency of medical affairs strategy and execution between regions (NA/EMEA/JAPAC), incorporating regional insights and supporting regional medical needs within the global medical strategy.
- Lead the development of medical communication platforms and scientific narratives for Rare Disease products across the lifecycle
- Partner with Global Development Organization to provide medical and strategic input into clinical development programs, including study design, protocol development and interpretation of results
- Provide medical and scientific input for the development of Life Cycle Management strategies
- Collaborate with the Franchise and commercial teams providing medical input into the Target Product Profile (TPP) of portfolio compounds and into Brand Plans
- Support payer/market access strategy with HEOR and Market Access colleagues.
- Conduct timely medical assessments for business development due diligence activities, as a medical and scientific expert, in partnership with the North American Medical Affairs head and North American business teams and global cross-functional teams
- Establish and chair regular global-regional medical affairs meetings and participate in Franchise and other cross-functional meetings
- Support the Global Research organization as requested with medical insights and expertise
- Participate in cross-functional leadership teams and governance committees
- Review and approve applicable medical, commercial, regulatory, quality and pharmacovigilance documents
Evidence Generation
- Develop and deliver global integrated evidence generation plans and evidence dissemination plans including specific needs for Phase 4/post-registration studies including HEOR and Real-World Evidence (claims databases, registries etc.).
- Oversee approval process and support for unsolicited investigator sponsored trial proposals
- Develop and implement post-marketing studies and/or registries, as needed in collaboration with HEOR/RWE
- Lead the development of publication strategies and medical communications plans
- Develop and implement pre-authorization Early Access Programs, as approved by enterprise governance bodies
External Engagement
- Establish and maintain strong relationships with key external experts, healthcare professionals, professional societies and patient advocacy groups
- Serve as a key medical expert and thought leader, representing Kyowa Kirin at scientific conferences, advisory boards and key stakeholder meetings
- Drive scientific exchange programs and medical education initiatives
- Collaborate with external research partners and academic institutions
Team Leadership and Development
- Build, mentor and lead a high-performing global-regional medical affairs team, in accordance with the principles of high-performing teams
- Ensure alignment in execution of medical affairs activities through Medical Directors, Medical Science Liaisons (MSLs), Medical Information, Medical Communications and HEOR teams within Rare Disease
- Ensure that medical personnel at global, regional and local levels are properly trained, equipped and aligned with consistent scientific and medical messages and tools
- Foster a culture of scientific excellence and continuous learning
- Manage budget and resources effectively
- Provide ethical and compliant leadership by example, embracing the Kyowa Kirin core values of integrity, innovation, teamwork/wa and commitment to life, and the Kyowa Kirin Kabegoe Principles
Governance and Compliance
- Ensure compliance with SOPs, ethical standards and regulatory requirements across all activities
- Collaborate with cross-functional stakeholders to maintain governance frameworks for rare disease products
Job Requirements:
Education
Medical degree (MD, DO, MBBS, or equivalent) required. Advanced training or specialization in Rare Disease, clinical medicine, or a relevant therapeutic area preferred.
Experience:
- Minimum 15 years of experience in the pharmaceutical, biotechnology, or related healthcare industry, including at least 10 years in Medical Affairs and progressive leadership responsibilities at the global or enterprise level.
- Deep medical and scientific expertise in Rare Diseases, with comprehensive knowledge of disease biology, genetics, diagnostics, clinical practice, and evolving treatment landscapes.
- Strong track record of shaping and executing global Medical Affairs strategies that enhance product value, differentiation, evidence generation, and lifecy