Global Medical Affairs Therapeutic Area Head, Rare Disease

Kyowa Kirin North America•Princeton, NJ

9d•$394,200 - $492,800

About The Position

The Global Medical Affairs Therapeutic Area Head, Rare Disease, provides strategic scientific and medical leadership for Kyowa Kirin’s Rare Disease portfolio. Reporting to the Global Head of Medical Affairs, this role is a member of the Global Medical Affairs Leadership Team and is accountable for developing and executing global Medical Affairs strategies and plans across the therapeutic area. The role leads global Rare Disease Medical Affairs strategic plans, covering evidence generation, scientific communications, publications, external partnerships, and launch readiness, aligned with business and franchise priorities. It works closely with Franchise, Regional Medical, HEOR, Patient Advocacy, Market Access, Commercial, Legal and Compliance, Regulatory Affairs, and R&D teams. The position also contributes medical input to clinical development and regulatory strategies, incorporating patient, physician, and payer perspectives and supporting health technology assessment and payer strategies. The role provides scientific and medical expertise to Business Development, Regional Medical, and Regional Business teams when evaluating and prioritizing potential assets, including due diligence and portfolio decisions, and supports partnership activities. It leads and develops a global-regional Medical Affairs team, fosters scientific excellence, and ensures activities meet applicable ethical, governance, and regulatory requirements. The position is expected to travel up to 50% domestically and internationally and involves a normal office environment with prolonged sitting and extensive computer work.

Requirements

Medical degree (MD, DO, MBBS, or equivalent).
At least 15 years of experience in the pharmaceutical, biotechnology, or related healthcare industry.
At least 10 years of Medical Affairs experience with progressive global- or enterprise-level leadership responsibilities.
Deep medical and scientific expertise in Rare Diseases, including disease biology, genetics, diagnostics, clinical practice, and evolving treatment landscapes.
Demonstrated success shaping and executing global Medical Affairs strategies across development and commercial stages, including product value, differentiation, evidence generation, and lifecycle management.
Significant experience across drug development, including clinical development, study and protocol design, clinical data interpretation, regulatory strategy, and post-marketing evidence generation.
Broad experience conducting medical and scientific due diligence on external assets, business development opportunities, partnerships, collaborations, and portfolio priorities.
Experience leading global, cross-functional, geographically dispersed teams and aligning regional and global strategies across markets.
Established relationships with key opinion leaders, healthcare professionals, professional societies, patient advocacy organizations, and academic or research institutions.
Ability to set strategic direction and make sound decisions in complex or ambiguous environments, translating scientific and medical insights into strategic priorities and actions.
Ability to assess and synthesize clinical, scientific, epidemiologic, health economics, and real-world evidence for strategic decisions.
Knowledge of global drug development processes, regulatory environments, and applicable legal, compliance, ethical, and pharmacovigilance requirements.
Ability to influence and align senior stakeholders across Medical Affairs, R&D, Regulatory, Market Access, HEOR, Commercial, and Patient Advocacy, including without formal authority.
Ability to connect medical and scientific priorities with business, franchise, asset value, and portfolio priorities while maintaining appropriate medical independence.
Ability to inspire, coach, develop, and align diverse teams and foster accountability, collaboration, scientific excellence, and continuous learning.
Strong written, verbal, presentation, and public-speaking communication skills for complex scientific and medical concepts.
Proficiency in MS Office Suite.
Excellent organization, prioritization, decision-making, and problem-solving abilities.
Strong work ethic, attention to detail, and follow-through.
Ability to adapt to ambiguity in a dynamic, fast-paced, high-growth matrix organization.
Interest in personal learning and development and cultural sensitivity in a multinational organization.
Ability to travel up to 50% domestically and internationally.
Ability to work in a normal office environment with prolonged sitting and extensive computer work.

Nice To Haves

Advanced training or specialization in Rare Disease, clinical medicine, or a relevant therapeutic area.

Responsibilities

Provide scientific, medical, and technical expertise on Rare Disease products, disease landscapes, and the development and marketed portfolio.
Develop and execute the global Medical Affairs strategy for the Rare Disease portfolio in alignment with franchise priorities and Integrated Asset Plans.
Contribute significantly to Integrated Asset Plans and Integrated Evidence Generation Plans.
Align global and regional Medical Affairs strategy and execution across North America, EMEA, and JAPAC, incorporating regional insights and needs.
Lead development of medical communication platforms and scientific narratives across the product lifecycle.
Partner with Global Development on clinical development strategy, study design, protocol development, and interpretation of results.
Provide medical and scientific input into lifecycle management strategies, Target Product Profiles, and Brand Plans.
Support payer and market access strategies with HEOR and Market Access colleagues.
Conduct medical assessments for business development due diligence and support asset evaluation, portfolio decisions, and partnering activities.
Establish and chair global-regional Medical Affairs meetings and participate in franchise, cross-functional, and governance meetings.
Support Global Research with medical insights and expertise as requested.
Review and approve applicable medical, commercial, regulatory, quality, and pharmacovigilance documents.
Develop and deliver global integrated evidence-generation and evidence-dissemination plans, including Phase 4 and post-registration studies, HEOR, and real-world evidence.
Oversee the approval process for, and support, unsolicited investigator-sponsored trial proposals.
Develop and implement post-marketing studies and registries in collaboration with HEOR and RWE teams as needed.
Lead publication strategies and medical communications plans.
Develop and implement pre-authorization Early Access Programs, subject to enterprise governance approval.
Build, mentor, and lead a high-performing global-regional Medical Affairs team.
Align execution across Medical Directors, MSLs, Medical Information, Medical Communications, and HEOR teams within Rare Disease.
Ensure global, regional, and local medical personnel are trained, equipped, and aligned on scientific messages and tools.
Foster scientific excellence and continuous learning; manage budgets and resources effectively.
Establish and maintain relationships with external experts, healthcare professionals, professional societies, patient advocacy groups, research partners, and academic institutions.
Represent Kyowa Kirin at scientific conferences, advisory boards, and stakeholder meetings; lead scientific exchange and medical education initiatives.
Ensure compliance with SOPs, ethical standards, regulatory requirements, and product governance frameworks.
Provide ethical and compliant leadership consistent with Kyowa Kirin’s values and Kabegoe Principles.

Benefits

401(k) with company match
Annual bonus program
Generous paid time off and holiday schedule, including summer and winter shutdowns, sick days, and volunteer days
Medical, dental, prescription drug, and vision coverage
Health savings account and flexible spending account programs
Well-being and work-life programs
Life and disability insurance
Concierge services
Long-term incentive program, subject to job level and performance
Pet insurance
Tuition assistance
Employee referral awards