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Global Medical Affairs Therapeutic Area Head, Oncology

Princeton, New Jersey

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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

The Global Medical Affairs Therapeutic Area Head, Oncology, will provide strategic scientific and medical leadership and direction for all medical affairs activities across the oncology portfolio in Kyowa Kirin. This senior role will report to the Global Head of Medical Affairs and a key member of the Global Medical Affairs Leadership Team. 

This role will be accountable for the planning and delivery of the Oncology Global Medical Affairs Strategic Plan (e.g., evidence generation, scientific communication strategy, external partnerships, etc.), ensuring alignment with business and franchise priorities, and in collaboration with internal stakeholders, including (but not limited to) regional medical teams, Health Economics Outreach Research (HEOR, Patient Advocacy, Market Access, Commercial, Legal, Compliance, and Research and Development (R&D). 
This role will partner with and provide input into R&D and Regulatory Affairs to help shape clinical development and regulatory plans in the Oncology Therapeutic Area (TA), considering patient, physician, and payor needs.

Strategic Leadership and Medical Direction
•    Provide comprehensive subject matter expertise and scientific, medical, and technical knowledge of products and disease area landscapes for the marketed and development portfolio within the Oncology TA. 
•    Develop and execute the Global Medical Affairs Strategy for the Oncology TA portfolio, including Global Medical launch plans, in alignment with business and franchise priorities.
•    Ensure consistency of medical affairs strategy and execution between regions (NA/EMEA/JAPAC), seeking regional insights and supporting regional medical needs within the global medical strategy.
•    Lead the development of medical communication platforms and scientific narratives for oncology products across the lifecycle.

•    Partner with the Global Development Organization to provide medical and strategic input into clinical development programs, including study design, protocol development, and results interpretation.
•    Provide medical and scientific input for developing Life Cycle Management strategies.
•    Collaborate with the Franchise and commercial teams, providing medical input into the Target Product Profile (TPP) of portfolio compounds and brand plans.
•    Support payor/market access strategy with HEOR and Market Access colleagues.
•    Participatein cross-functional leadership teams and governance committees to represent and advance Global Medical Affairs initiatives.
•    Review and approve applicable medical, commercial, regulatory, quality, and pharmacovigilance documents. 

Evidence Generation
•    Develop and implement a global integrated evidence generation plan for registries, including dissemination strategies and specific requirements for Phase 4/post-registration studies, such as HEOR and Real-World Evidence (including claims databases and registries).
•    Oversee approval process and support for unsolicited investigator-sponsored trial proposals.
•    Develop and implement pre-authorization Early Access Programs, post-marketing studies, and/or registries, as needed.
•    Lead the development of publication strategies and medical communications plans.

External Engagement
•    Establish and maintain compliant relationships with key external experts, healthcare professionals, and patient advocacy groups
•    Serve as a key medical expert and thought leader, representing the company 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 medical affairs team across multiple regions.
•    Ensure alignment in executing medical affairs activities through Medical Directors, Medical Science Liaisons (MSLs), Medical Information, Medical Communications, and Health Economics teams within the Oncology TA.
•    Foster a culture of scientific excellence, compliance, 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.
•    Strictly adhere to relevant regulatory and compliance guidelines and company policies

Education 
MD, board certified in Oncology (or equivalent).

Experience
In-depth medical knowledge and extensive experience in Oncology, with a focus on hematology/oncology.  Minimum 15 years’ experience in the pharmaceutical industry, with at least 10 years in medical affairs. Proven track record of leading medical affairs teams and programs at a senior level. A strong understanding of drug development, regulatory environments globally, and legal/compliance regulations. Exceptional leadership abilities with demonstrated success in building and developing teams. Strong scientific acumen and ability to understand and communicate complex clinical data. Excellence in stakeholder management and communication at all levels. Strategic thinking and decision-making capabilities with demonstrated success in delivering strategic, innovative oncology-specific medical vision and strategy. Deep understanding of medical affairs compliance requirements and industry regulations. Strong business acumen and ability to align medical strategy with franchise priorities. Experience leading global teams desirable, with demonstrated effective collaboration across cross-functional and geographical boundaries. Excellent communication skills across multiple media, including strong written, presentation, and public speaking skills.  

Technical Skills
Proficient in MS Office Suite.

Non-Technical Skills
Excellent organizational abilities, including prioritization, decision-making, and problem-solving. Strong interpersonal and communication skills. Strong work ethic. Detail-oriented and excellent follow-through. Ability to flex and deal with 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 within a multinational organization.

Travel
Requires up to 50% 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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