North America Head of Medical Affairs Operations & Excellence

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.

Summary of Job:

The North America Head of Medical Affairs Operations & Excellence is a senior leadership role responsible for advancing the strategic, operational, and organizational effectiveness of the North America Medical Affairs function. With regional accountability and strong partnership across Global Medical Affairs, this leader drives integrated planning, governance, resource optimization, performance management, and execution excellence to support the organization's scientific and business objectives.

The role provides leadership and oversight for Medical Affairs operations and directly manages the North America Medical Affairs Project Management team. As a key member of the Medical Affairs leadership ecosystem, the Head of Medical Affairs Operations & Excellence partners closely with regional and global stakeholders to align priorities, enable cross-functional execution, optimize portfolio delivery, and foster a culture of continuous improvement, scalability, and operational rigor across the organization.

Essential Functions:

Medical Affairs Operations & Strategy Enablement

• Lead the design, implementation, and continuous improvement of Medical Affairs operational models across North America.
• Translate Medical Affairs strategy into integrated operational plans, timelines, and execution frameworks across therapeutic areas and assets.
• Partner with North America Medical Affairs leadership to support annual planning, goal setting, prioritization, and resourcing decisions.
• Enable effective execution across the Medical Affairs portfolio by driving clarity of roles, responsibilities, decision rights, and interdependencies.
• Provide regional accountability for North America Medical Affairs systems and tools (e.g., planning, tracking, and performance management platforms), ensuring fit-for-purpose use, alignment with global standards, and continuous optimization.
• Oversee North America Medical Affairs operating budgets, including planning, forecasting, tracking, and optimization of spend in partnership with Finance and Global Medical Affairs counterparts.
• Oversee promotional/non-promotional review process

Project Management & Execution Excellence

• Oversee a team of Medical Affairs project managers responsible for planning and execution of key Medical Affairs initiatives, programs, and milestones.
• Establish standardized project management methodologies, tools, and best practices across Medical Affairs.
• Ensure consistent tracking, reporting, and escalation of risks, dependencies, and execution issues across the portfolio.
• Drive on-time, high-quality delivery of Medical Affairs initiatives through strong governance and disciplined execution.

 Governance, Processes & Ways of Working

• Lead Medical Affairs governance forums and operating rhythms, including portfolio reviews, planning meetings, and leadership updates.
• Establish and maintain clear processes for intake, prioritization, execution, and decision-making across Medical Affairs activities.
• Partner with Regulatory, Legal, Compliance, and other functions to ensure Medical Affairs operations align with internal policies and external requirements.
• Drive simplification and efficiency by identifying and addressing process gaps, redundancies, and operational pain points.

 Performance Management & Insights

• Define and implement performance metrics, dashboards, and reporting to track Medical Affairs execution, impact, and resource utilization.
• Enable data-driven decision-making through clear insights into progress, risks, and outcomes.
• Support continuous improvement by using performance insights to inform planning, prioritization, and operational enhancements.
• People Leadership & Capability Building
• Lead, develop, and mentor a team of Medical Affairs project managers, fostering a culture of accountability, collaboration, and operational excellence.
• Build project management and operational capabilities across the Medical Affairs organization through training, coaching, and best practice sharing.
• Support talent development, succession planning, and future capability needs as the portfolio and organization evolve.

 Cross-Functional Leadership & Strategic Partnership

• Serve as a strategic operational partner to the North America Medical Affairs Leadership Team, Therapeutic Area and Asset Leads, and Medical Affairs functional leaders.
• Foster alignment, transparency, and effective execution across Medical Affairs, including Project Management, Scientific Communications, Medical Education, and Field Medical teams.
• Partner closely with Clinical Development, HEOR, Regulatory Affairs, Commercial, Finance, Legal, and Compliance to enable integrated planning, decision-making, and execution.
• Collaborate with the Global Medical Affairs Office Head and Global Medical Affairs Operations/Strategy counterparts to ensure alignment of regional priorities with global objectives and best practices.
• Act as a key connector across functions and geographies, facilitating communication, managing interdependencies, and driving seamless execution of Medical Affairs initiatives.

 Decision-Making Authority

• Accountable for Medical Affairs operational frameworks, execution standards, and performance management across North America.
• Authority to establish project management methodologies, tools, and reporting standards.
• Operational escalation authority for execution risks, resource constraints, and cross-functional dependencies.
• Input into Medical Affairs resourcing, prioritization, and organizational design decisions.

Job Requirements:

Education

Bachelor's degree in Life Sciences, Business Administration, Project Management, or a related field required. Advanced degree in a scientific, clinical, or healthcare-related discipline strongly preferred (e.g., MD, PharmD, PhD, MSN, or equivalent).

 Experience

• Minimum of 12 years in the pharmaceutical/biotechnology industry, including at least 6 years within Medical Affairs.
• Demonstrated leadership in Medical Affairs Operations, strategic planning, portfolio management, or enterprise project management functions.
• Proven success leading project managers, operational teams, and/or matrixed organizations.
• Track record of supporting Medical Affairs strategy development and execution across multiple therapeutic areas, assets, and stages of the product lifecycle.
• Strong understanding of Medical Affairs governance, operating models, and cross-functional collaboration within a matrix environment.
• Knowledge of evidence generation activities, including investigator-sponsored studies (ISS), collaborative research, medical publications, and real-world evidence initiatives.
• Solid understanding of clinical development processes and the role of Medical Affairs in lifecycle management, scientific engagement, and brand strategy.
• Demonstrated ability to lead portfolio prioritization, resource planning, governance, and performance management processes.
• History of effective partnership with Clinical Development, Regulatory Affairs, HEOR, Commercial, Legal, Compliance, and Finance functions to drive integrated planning and execution.
• Familiarity with global and regional organizational structures, including alignment of regional priorities with global strategies, processes, and governance frameworks.

Technical Skills & Competencies

• Strong understanding of Medical Affairs operating models, governance structures, and the role of Medical Affairs across the product lifecycle.
• Demonstrated expertise in strategic planning, portfolio management, resource planning, and organizational prioritization within a complex matrix environment.
• Advanced knowledge of Medical Affairs planning and execution, including evidence generation, scientific communications, medical education, field medical, and investigator-sponsored research activities.
• Strong understanding of clinical development, regulatory requirements, compliance standards, and industry guidelines relevant to Medical Affairs operations.
• Proven ability to establish and optimize operational processes, governance frameworks, performance metrics, and business planning capabilities that drive organizational effectiveness and scalability.
• Exceptional leadership and stakeholder management skills, with the ability to influence and align diverse cross-functional and global stakeholders without direct authority.
• Strong business acumen and strategic thinking, with the ability to translate organizational priorities into actionable operational plans and measurable outcomes.
• Excellent communication and presentation skills, with the ability to effectively engage senior leaders and facilitate decision-making across complex organizations.
• Strong analytical and problem-solving capabilities, including the use of data and performance insights to support decision-making, resource allocation, and continuous improvement initiatives.
• Proficiency with business planning, project portfolio management, reporting, and collaboration tools; advanced proficiency in Microsoft Office applications, including PowerPoint and Excel.

Non-Technical Skills

Ability to thrive in a fast-paced environment while managing ambiguity effectively. Strong work ethics are required. Passion for personal learning and professional development. Cultural sensitivity and adaptability within multinational organizations.

The anticipated salary for this position will be $300,000 to $330,000.  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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