US Rare Disease Company
US Rare Disease Company
The Director, Head of Health Economics and Outcomes Research (HEOR) in JAPAN is responsible for the strategic development and execution of health economics and outcomes research strategies to support the access and reimbursement of products across the portfolio and therapeutic disease areas in Japan. The position is part of the global HEOR team.
Through key leadership and partnership across cross-functional teams, the job holder embeds global HEOR strategy into broader disease area and clinical development strategies relevant for the Japanese market and its requirements. This collaboration builds strategies to demonstrate and differentiate the value proposition and corresponding scientific evidence of products to Health Technology Assessment agencies, patients, clinical institutions and other key influencers in Japan. The Director, HEOR, Japan, partners with and provides thought leadership to Value & Access, Pricing, Governmental Affairs, Clinical Development, Medical Affairs and Commercial teams as well as to other regions and countries. This role reports directly to the Head of HEOR International & Japan. The Director will work in close collaboration with the Global HEOR TA leads and the lead for GHEOR International and partner with Medical Affairs and Value Access and Policy teams to ensure compelling scientific evidence for value is generated and communicated to meet the needs for patient access in Japan.
Utilizes in-depth knowledge of disease area and portfolio strategy in combination with health economics and outcomes research to develop, adapt and execute the Global HEOR strategy for Japan. Responsible for setting up and providing input into the study design of retrospective observational studies using disease registries and existing Japanese claims databases such as JMDC and MDV. Ensures Japanese payer and HTA relevant endpoints and evidence generation strategies are implemented throughout the product lifecycle. It is essential to build and establish working relationships with the Japanese government. This position is responsible for, but not limited to, the following:
Manages and oversees analysts and medical writers of real world evidence (RWE) studies.
Assesses and evaluates HEOR vendors from a quality, experience and cost perspective.
Builds collaborative relationships with cross-functional leaders across Medical Affairs, Commercial, Governmental Affairs and Market Access organizations to maximize evidence generation efforts to optimize launch and sustained reimbursement throughout the product lifecycle
Develops, drives, executes and disseminates innovative HEOR and RWE studies for Japan.
Drives the cross functional HTA dossier development for new products and indications.
Partners with the Therapeutic Area (TA) heads in the Japanese affiliate to provide HEOR input to TA business strategies and clinical development plans that will provide a competitive advantage to differentiated payer and HTA evidence.
Continually monitors the global marketplace for market access issues, identifies access/demand hurdles and creates plans to demonstrate the value and differentiation of assets within the therapeutic area portfolio • Ensures the company maintains external credibility and relationships to validate research findings and communications. Accountable for the following:
Cultivates and maintains relationships with key experts, influencers, and customer segments to foster and maintain the company’s credibility to support the value and reimbursement of products • Delivers presentations on behalf of the company at various industry and scientific forums and/or contribute to publications
Maintains the relationship with external Japanese HEOR agencies and monitors their performance to ensure that performance and deliverables meet business expectations
Provides HEOR leadership and guidance for the Japanese affiliate making sure the affiliate has access to the most relevant, up to date and appropriate HEOR tools needed to gain, maintain and improve patient access for the therapeutic area responsibilities.
Develops best practices in HEOR including approaches to areas including research methodologies, study designs, endpoints that provide scientifically sound protocols, policies, tools and outcome impact.
Identify areas for process improvements, economies of scale, and other quality and efficiency measures
PhD, MSc in health economics or equivalent combination of education and experience
7+ prior experience in HEOR or Market Access in the biopharmaceutical/pharmaceutical industry
In depth understanding and experience of health economic modeling, preferably previous hands on experience.
Statistical and epidemiological expertise in analyzing real world data using primary and secondary Japanese data such as JMDC and MDV.
Experience from working and negotiating with the Japanese HTA agencies and/or Ministry of Health.
Thorough understanding of the field of Health Technology Assessment in Japan and some experience working at a global level and experience of successful negotiations through the HTA processes
Knowledge of the drug development and commercialization process
Demonstrated ability to lead and deliver results in a matrix environment, and solve complex issues that cross multiple stakeholder
Excellent interpersonal skills with a track record of effectiveness as a team player; excellent oral/written communication and presentation skills
Excellent project leader who can effectively manage multiple competing priorities to completion • Global mindset and ability to work with multicultural teams
Flexibility and adaptability to internal and external change
Fluent in Japanese spoken and written
[Must currently reside in Japan]