HEOR Manager or Senior Staff will be responsible for and lead the development and implementation of the evidence generation strategy to maximize Boehringer Ingelheim asset value and optimize access to medicines through product life cycle from early stage of clinical development to post-market.
Accountabilities
Develop HEOR generation strategy and efficiently implement relevant research targeting various stakeholders for optimizing access to Nippon Boehringer Ingelheim Co., Ltd products through the life cycle from the early pipeline stage of the clinical development to the post-launch, and achieve effective dissemination of evidence under complying with compliance.
Related performance indicators
1. Develop the evidence generation strategy to maximize the asset values trough the collaboration with AT/eEL, and inputs local needs to corporate asset strategy and deliverables(AEP, IAP etc)
2.For responsible asset work on HEOR strategy discussions cross-functionally and lead the HEOR studies including RWE generation.
3.Have a responsibility for the whole process of evidence generation including study planning, medical writing, publication materials and dissemination of the results.
Assess COAs including utility in clinical development, and validate or newly develop COA tools thorough the collaboration with corporate AT/corporate HEOR
Related performance indicators
1. Lead the evaluation and study of COAs such as PRO/QOL tools in clinical trials.
２．Lead discussions on validation and new development of PRO/QOL tools and prepare the optimal PRO/QOL/utility instrument for maximizing product value and J-HTA evaluation.
Plan and prepare for the Japanese HTA(J-HTA) system, and develop negotiation strategy with the authority
Related performance indicators
1. Inputs local needs to global health economic model and relevant global deliverables
2. Lead local adaptation of a global model with local data generation, and responsible for J-HTA dossier preparation
3. Develop negotiation strategy and responsible for execution for its
Understand related laws and guidelines and the trend of discussions in Japan and globally through the dialogues with HEOR/HTA experts, such as the data platform / drug price system / cost-effectiveness evaluation system and provide the latest situation into company/asset strategy appropriately’
Related performance indicators
・Conduct the opportunity/risk assessment of the impact of current/future trends of regulation and guideline related HEOR/HTA on the pharmaceutical industry and Boehringer Ingelheim Japan.
・Build relationship with the experts in HEOR/HTA
Regulatory and / or Organisational Requirements
•The following knowledge is required for job performance.
・ Epidemiology
・ Biostatistics
・ Health economics
・ Design and evaluation of observational studies
・ PRO / QOL evaluation
・ Medical insurance system, drug price system, J-HTA
・ Medical insurance system and healthcare technology evaluation system in other countries
Job Complexity
Appropriately and timely grasp changes in the external environment related to HEOR, such as the HTA system and RWE in both of Japan and overseas. Predict the impact on the pharmaceutical industry and companies and develop and implement strategies.
Take charge of the whole process of HEOR-related evidence generation activities including evidence generation strategy, implementation of the analysis, medical writing, publication, in collaboration with relevant internal x-functional team
3. Responds promptly to other internal and external requirements and issues with flexibility.
Interfaces
Boehringer Ingelheim:Corporate HEOR, Global Market Access
Nippon Boehringer Ingelheim Co., Ltd: MKT, Medicine(TA, CD, PM, Epi, BDS),Market Access Pricing, PE,CMO...
External stakeholders: MHLW, Core2Health, Academia, Vendor, Industry associations(JPMA, EFPIA)
Job Expertise
・HEOR and RWE related activities including health economic evaluation, outcomes research, evidence strategy planning, analysis, medical writing, publication
・Strategy development and project management/lead of cross-functional projects
・Scientific discussions with external medical experts, health economics experts, and RWE experts
Job Impact
Maximize patient access to BI assets by implementing evidence generation strategy aiming at maximization of asset value and optimization of market access, and minimization of the risk of post-launch price adjustments under the HTA system. Contribute greatly to the realization of sustainable NBI business.
Minimum Education/Degree Requirements
Master or PhD in public health (epidemiology, clinical epidemiology, pharmacoepidemiology, PRO / QOL, qualitative research, etc.), or pharmacoeconomics or health economics
Required Capabilities (Skills, Experience, Competencies)Knowledge of epidemiologyKnowledge of biostatisticsKnowledge of health economicsKnowledge of observational studiesExperience in health economic evaluation model, observational research and PRO / QOL research (until publication)Capability or experiences of development of HEOR/RWE strategyExpertise and capability to have scientific discussions with external medical experts and health economic expertsInterpersonal skills that enable smooth and productive relationships with internal and external stakeholdersKnowledge of Japanese medical insurance system, drug price system, HTA systemKnowledge of medical insurance systems and medical technology evaluation systems in other countriesSkills to carry out work in English on a daily basis
Recruiter：K Nagai