Global Medical Affairs Therapeutic Area Head, Rare Disease

Kyowa Kirin•Princeton, NJ

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, the 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 position leads global Rare Disease Medical Affairs strategic plans, including evidence generation, scientific communications, publications, external partnerships, and launch readiness, in alignment 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 role provides medical input to clinical development and regulatory strategies, incorporating patient, physician, and payer perspectives and supporting health technology assessment and payer strategies. It also provides medical and scientific expertise to Business Development and regional teams in evaluating potential assets, conducting due diligence, making portfolio decisions, and executing partnerships. The role leads and develops a global-regional Medical Affairs team, fosters scientific excellence and ethical, compliant practice, and represents Kyowa Kirin with external medical and scientific stakeholders. The position requires up to 50% domestic and international travel and is based in 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, including at least 10 years in Medical Affairs and 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.
A strong record of shaping and executing global Medical Affairs strategies that enhance product value, differentiation, evidence generation, and lifecycle management across development and commercial stages.
Significant experience across the drug development lifecycle, including clinical development, study and protocol design, clinical data interpretation, regulatory strategy, and post-marketing evidence generation.
Broad experience in medical and scientific due diligence, including evaluation of external assets, business development opportunities, partnerships, collaborations, and portfolio priorities.
Experience leading global, cross-functional, geographically dispersed teams and aligning regional and global Medical Affairs strategies across markets.
Established relationships with external scientific and medical stakeholders, including key opinion leaders, healthcare professionals, professional societies, patient advocacy organizations, and academic or research institutions.
Ability to set strategic direction, make sound decisions in complex and ambiguous environments, and translate scientific and medical insights into strategic priorities and actions.
Ability to assess complex scientific, clinical, epidemiologic, health economics, and real-world evidence and translate insights into actionable recommendations.
Knowledge of global drug development processes, regulatory environments, and applicable legal, compliance, ethical, and pharmacovigilance requirements.
Ability to influence and align senior cross-functional stakeholders, including when formal authority is limited, while maintaining appropriate medical independence.
Ability to inspire, coach, develop, and align diverse teams and foster scientific excellence, accountability, collaboration, and continuous learning.
Strong written, verbal, presentation, and public-speaking skills for communicating complex scientific and medical concepts.
Proficiency in MS Office Suite.
Excellent organizational, 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 environment and matrix organization.
Passion and curiosity for personal learning and development.
Cultural sensitivity and ability to develop consensus in a multinational organization.
Ability to travel domestically and internationally up to 50%.

Nice To Haves

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

Responsibilities

Provide subject matter expertise and scientific, medical, and technical knowledge of Rare Disease products and disease-area landscapes across marketed and development portfolios.
Contribute significantly to Integrated Asset Plans and Integrated Evidence Generation Plans.
Develop and execute the global Medical Affairs strategy for the Rare Disease portfolio in alignment with business, franchise, and Integrated Asset Plan priorities.
Promote consistency of Medical Affairs strategy and execution across NA, EMEA, and JAPAC, incorporating regional insights and needs.
Lead development of medical communication platforms and scientific narratives for Rare Disease products throughout their lifecycle.
Partner with Global Development on medical and strategic input for clinical development programs, including study design, protocol development, and interpretation of results.
Provide medical and scientific input to lifecycle management strategies, Target Product Profiles, Brand Plans, and payer and market access strategies.
Conduct medical assessments for business development due diligence and support evaluation of assets, partnerships, and portfolio decisions.
Establish and chair regular global-regional Medical Affairs meetings and participate in Franchise, cross-functional, leadership, and governance meetings.
Support the Global Research organization 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 or post-registration studies, HEOR, and real-world evidence.
Oversee approval processes and provide support for unsolicited investigator-sponsored trial proposals.
Develop and implement post-marketing studies and registries in collaboration with HEOR and RWE colleagues.
Lead publication strategies and medical communications plans.
Develop and implement pre-authorization Early Access Programs when approved by enterprise governance bodies.
Build and maintain relationships with external experts, healthcare professionals, professional societies, and patient advocacy groups.
Represent Kyowa Kirin as a medical expert and thought leader at scientific conferences, advisory boards, and stakeholder meetings.
Drive scientific exchange programs and medical education initiatives and collaborate with external research partners and academic institutions.
Build, mentor, and lead a high-performing global-regional Medical Affairs team.
Align Medical Directors, MSLs, Medical Information, Medical Communications, and HEOR teams in execution of Rare Disease Medical Affairs activities.
Ensure medical personnel at global, regional, and local levels are trained, equipped, and aligned on consistent scientific and medical messages and tools.
Foster scientific excellence and continuous learning, and manage budgets and resources effectively.
Model ethical and compliant leadership consistent with company values and Kabegoe Principles.
Ensure compliance with SOPs, ethical standards, and regulatory requirements, and collaborate with stakeholders to maintain product governance frameworks.

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
Healthcare benefits, including medical, dental, prescription drug, and vision coverage
HSA and FSA 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