Head of Evidence Generation, COA HTA and PED

About the Role

The Head of HTA, COA, and PED in Global Evidence Generation is responsible for leading a team of experts to develop, validate, and execute fit-for-purpose clinical outcome assessment (COA) endpoints, patient experience data (PED) strategies and high-quality evidence generation to support health technology assessment (HTA) and payer differentiation around the world.

This highly strategic role will drive early and innovative strategic decision making and high-quality execution for clinical outcome assessment, PRO (patient reported outcomes), and PED to support study execution, labeling, differentiation, payer and HTA interactions, and patient focus, in collaboration with internal and external stakeholders. They will engage actively with internal and external bodies to shape and interpret the rapidly changing requirements from global health authorities and build partnerships to shape methods and guidelines.

How You Will Contribute

• Lead a team of experts focused on clinical outcome assessment endpoint development, validation, execution, and quality control across regulatory, payer, physician, and patient needs
• Drive the generation and communication of high-quality, fit-for-purpose evidence to support health technology assessment and other payer evaluations globally to demonstrate the value of Takeda's assets
• Lead early strategic review of clinical outcome assessment selection and implementation to support study execution, labeling, differentiation, payer and health technology assessment discussions, and patient focus
• Train and monitor clinical outcome assessment raters to ensure quality, consistency, and compliance
• Develop team expertise in health technology assessment methods in a rapidly changing environment, with a focus on Joint Clinical Assessment and the Inflation Reduction Act
• Build capabilities in clinical outcome assessments and patient experience data, with an emphasis on using these tools to differentiate and demonstrate value
• Accelerate evidence generation processes and strengthen alignment with local country teams to support scientifically robust, timely launches and health technology assessment submissions
• Build and sustain external partnerships that help influence methods and guidelines for the evolving regulatory and access environment
• Represent Takeda in external interactions with health authorities, payers, and external organizations focused on patient experience data, clinical outcome assessment, and health technology assessment
• Ensure strong compliance with evolving requirements from global regulatory agencies and health authorities
• Drive operational excellence through clear governance, prioritization, resource allocation, and performance metrics
• Coach, develop, and retain a high-performing team; support succession planning and capability building across the function

Preferred Qualifications

• Fifteen or more years of experience in evidence generation, health technology assessment, clinical outcome assessment, patient experience data, or a closely related field
• Advanced degree in a scientific, clinical, epidemiologic, quantitative, or health outcomes discipline required
• Deep knowledge of study design, healthcare data analysis, clinical outcome assessment, health system landscaping, and the regulations and guidelines related to health technology assessment, clinical outcome assessment, and patient experience data
• Proven experience leading teams of experts and building capability in a complex and rapidly evolving global environment
• Strong track record of working with health authorities, payers, and external organizations
• Experience with evidence generation strategies that support global access, regulatory, and value communication needs
• Ability to build cross-functional alignment and support timely evidence generation for launches and submissions
• Understanding of clinical outcome assessment rater training, monitoring, and quality processes and guidelines
• Advanced knowledge of health technology assessment methods, with experience in a rapidly changing policy environment