14 часов назад
Associate Director or Senior Manager, Value Evidence and Outcomes (Biopharma)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director or Senior Manager, Value Evidence and Outcomes (Biopharma) (HEOR/HTA): Planning and executing Japan evidence-generation strategies for serious and rare disease therapies with an accent on health economics, outcomes research, real-world data, and regulatory compliance. Focus on designing and managing company-sponsored and observational studies, developing cost-effectiveness analyses, and translating evidence into medical, pricing, and publication strategies.
Location: Tokyo office with weekly flexibility in a hybrid work environment; occasional domestic and global travel up to 30%
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Plan and execute Japan evidence-generation strategies aligned with medical strategies, HEOR priorities, brand plans, and business objectives.
- Identify data gaps and resolvable unmet medical needs through literature research, expert insights, and health technology assessment approaches.
- Design and manage interventional and observational studies, patient-reported outcomes research, pre-existing dataset analyses, Delphi panels, and AI-enabled algorithms.
- Lead company-sponsored studies, including vendor management, feasibility, budgets, timelines, approvals, and compliance with GCP and Japanese regulations.
- Develop epidemiological and cost-effectiveness evidence to support clinical trials, J-NDA submissions, pricing, and market access.
- Collaborate with Medical Affairs, HEOR, Clinical Development, Commercial, Market Access, Pricing, Patient Advocacy, Publication, and external stakeholders.
Requirements
- Master’s degree in a scientific discipline or equivalent experience; PhD, PharmD, or MD preferred.
- At least 10 years of relevant pharmaceutical or biotech experience in a global Japan setting, including at least 5 years in evidence generation.
- Experience with at least two company-sponsored GCP studies, one PMS study, two PRO studies, and five studies using pre-existing datasets.
- Strong knowledge of evidence-generation methods, study planning, protocols, statistical analysis plans, vendor management, expert consultations, budgets, and timelines.
- Native-level Japanese and high-level business English are required.
- Understanding of Japan’s HTA system and MHLW cost-effectiveness analysis guidelines; TreeAge experience is valued.
Nice to have
- Experience in pulmonology, bacterial infection, cardiovascular disease, or allergy and immunology.
- HTA certification, systematic reviews and meta-analyses, Delphi consensus development, commercial database studies, or AI-based diagnostic and disease-progression algorithms.
- Active Japanese medical license for MD holders and relevant board certification.
Culture & Benefits
- Flexible working hours and vacation programs supporting work-life balance.
- Retirement benefits, equity compensation, and an employee stock purchase plan.
- Internal and external training, LinkedIn Learning, and specialized professional development.
- AI-enabled learning tools, digital assistant resources, global recognition programs, and employee resource groups.
- Hybrid-work technology and IT support for collaboration across locations and time zones.
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