Sr. Director, TA Head North America Rare Disease

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario.

Job Summary:

The Sr. Director, TA Head North America Rare Disease leadership is accountable for the end-to-end regional medical and scientific leadership of a therapeutic area franchise. The role owns the regional therapeutic area vision, strategy, and priorities across multiple assets spanning early development, pre-launch, launch, and lifecycle management, while addressing the needs of diverse stakeholders.

As a senior medical leader, this position provides enterprise-level leadership across the region and directly leads a team of Asset Medical Leads. The role is responsible for ensuring scientific excellence, strategic alignment, and high-impact execution across the portfolio. While not directly managing Field Medical teams, the TA Head drives strategic direction and priorities for MSL leadership, ensuring aligned execution and the availability of high-quality scientific communication materials.

The role partners closely with Medical Affairs Operations & Excellence, MSL leadership, and Global Medical Affairs to ensure regional strategies are aligned with global direction, appropriately resourced, and effectively executed across the product lifecycle.

Essential Functions:

Therapeutic Area Franchise Leadership

• Own the regional therapeutic area medical vision and long-term strategy, aligned with global medical strategy and regional priorities.
• Provide strategic oversight across all assets within the therapeutic area, ensuring coherence across development stages and target audiences.
• Serve as the primary regional medical authority and advisor for the therapeutic area to senior Medical Affairs and enterprise leadership.
• Accountable for scientific quality, strategic consistency, and medical impact across the therapeutic area portfolio.

 

Asset & Portfolio Oversight

• Provide direct leadership and direction to Asset Medical Leads and/or scientific communication leads.
• Set strategic priorities, success metrics, and performance expectations across assets.
• Drive balanced portfolio decision making across assets with differing maturity, risk, and stakeholder needs.
• Ensure effective integration of insights, evidence generation, and medical activities across the therapeutic area.
• Guide Scientific Communications Lead to ensure alignment of scientific narratives, publications, congress strategy, and medical content.

Early Development, Pre-Launch & Launch Accountability

• Shape and approve regional medical strategy for pipeline and early-stage assets, including scientific positioning, evidence needs, and external engagement approaches.
• Provide strategic medical input into clinical development activities, including study design and protocol development, to ensure regional relevance and support FDA regulatory expectations and submission strategies.
• Partner with Clinical Development, Regulatory Affairs, Global Medical Affairs, and Global HEOR to incorporate regional scientific, clinical practice, and regulatory considerations into development plans.
• Own regional medical pre-launch and launch readiness for assets within the therapeutic area, ensuring timely development of disease education, data dissemination, and stakeholder engagement strategies.
• Partner with Global Medical Affairs and Clinical Development to ensure regional needs inform global development and launch plans.
• Serve as the regional medical escalation point for launch critical scientific, strategic, or reputational risks.

Future Pipeline Expansion & Therapeutic Area Growth

This role is accountable for preparing the therapeutic area to successfully support future pipeline expansion, including new assets, indications, modalities, and evolving stakeholder landscapes.

• Anticipate future scientific, organizational, and capability needs associated with pipeline growth within the therapeutic area.
• Inform regional resourcing, capability building, and operating model evolution in partnership with Medical Affairs Operations & Excellence.
• Ensure medical strategy, evidence planning, and engagement models scale appropriately as the therapeutic area expands.
• Act as a strategic thought partner to regional and global leadership on future state therapeutic area readiness.

Field Medical Strategic Direction (Non-Line Management)

• Provide clear scientific priorities and strategic guidance to Field Medical and Field Medical leadership to inform execution.
• Advise on field medical focus areas, key messages, and engagement strategies while respecting reporting structures.
• Ensure field insights are systematically incorporated into therapeutic area and asset strategy.

Cross-Functional & Global Partnership

• Partner closely with Medical Affairs Operations & Excellence to support planning, prioritization, governance, and execution.
• Work in close partnership with MSL leadership, Medical Education, HEOR, Regulatory, Legal, and Compliance to ensure integrated and compliant execution.
• Provide regional medical and scientific input into Business Development activities, including asset evaluation, due diligence, and strategic assessment of external opportunities, to inform therapeutic area growth and portfolio decisions.
• Partner with Clinical Development and Regulatory Affairs to ensure medical insights from due diligence and development programs inform clinical and regulatory strategy.
• Represent the region in global therapeutic area governance and strategy forums as appropriate.

Governance, Quality & Compliance

• Ensure all therapeutic area activities comply with internal governance, SOPs, and external regulatory requirements.
• Serve as a senior scientific reviewer and escalation point for complex scientific or strategic issues within the therapeutic area.

Key Interfaces

• Head of North America Medical Affairs
• Medical Affairs Operations & Excellence
• Scientific Communications Leadership
• MSL / Field Medical Leadership
• Asset Medical Leads Respective Scientific Communication Lead
• Global Medical Affairs and Global Therapeutic Area Leadership
• Clinical Development, HEOR, Regulatory, Legal, and Compliance partners
• Commercial and Franchise Leadership and Teams

Decision Making Authority

• Accountable for regional therapeutic area medical strategy, priorities, and outcomes.
• Authority to set strategic medical direction across assets within the therapeutic area.
• Owns regional therapeutic area Medical Affairs budget accountability, including TA level planning, forecasting, prioritization, and optimization of spend, in partnership with Medical Affairs Operations & Excellence and Finance.
• Input into therapeutic area resourcing, portfolio prioritization, and organizational design decisions.
• Escalation authority for scientific, strategic, and reputational risks within the therapeutic area.
• Input into therapeutic area resourcing, portfolio prioritization, and organizational design decisions.

Job Requirements:

Education

Advanced scientific degree required (MD preferred, PhD, PharmD, or equivalent in a relevant scientific discipline. Additional business or leadership training (e.g., MBA, executive leadership programs) highly desired.

 

Experience

• Minimum of 15 years of experience in Medical Affairs or related functions within the pharmaceutical or biotechnology industry, with significant leadership responsibility.
• Demonstrated success in defining and executing medical strategy across multiple assets and lifecycle stages (early development through post-launch).
• Proven experience leading and developing senior medical leaders (e.g., Asset Medical Leads, Scientific Leads) within a matrixed organization.
• Strong understanding of Field Medical models, including MSL strategy, launch readiness, and Medical Affairs governance.
• Experience in rare disease or specialty therapeutic areas, with an understanding of complex stakeholder ecosystems
• Demonstrated ability to operate at an enterprise level, influencing cross-functional and global stakeholders to drive strategic alignment.
• Strong track record of delivering high-impact scientific engagement and communication strategies across diverse audiences.

 

Technical Skills

• Strong scientific credibility combined with enterprise-level strategic thinking and the ability to translate science into actionable strategy.
• Proven ability to lead leaders and influence across a highly matrixed, cross-functional, and global organization.
• Excellent judgment and decision-making skills, with strong stakeholder engagement and executive presence.
• Ability to synthesize complex scientific, operational, and organizational inputs into clear, aligned strategic direction.
• Exceptional written and verbal communication skills, with the ability to effectively engage diverse audiences, including senior leadership and external stakeholders.
• High level of accountability, collaboration, and leadership presence, with a focus on driving results and organizational alignment.
• Proficiency in Microsoft Office Suite (e.g., PowerPoint, Excel, Word) to support strategic communication, data analysis, and executive reporting

 Non-Technical Skills

Strong management skills with demonstrated ability to plan for resourcing needs, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individual’s skills, talents and career interests to ensure talent development. Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. A 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. Ability to drive or fly to meetings

Working Conditions: Requires up to 50% domestic and international travel, including some weekend commitments

The anticipated salary for this position will be $256,800 to $335,400. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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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