обновлено 12 часов назад
Medical Strategy Lead (NTM)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Strategy Lead (NTM) (Biopharmaceutical Medical Affairs): Leading medical strategy, scientific exchange, clinical development support, and governance for NTM programs in Japan with an accent on cross-functional leadership, regulatory compliance, and stakeholder engagement. Focus on developing the Japan Medical Affairs Plan, engaging PMDA and MHLW, translating scientific insights into strategy, and managing complex product lifecycle activities.
Location: Based out of the Tokyo office with weekly flexibility; occasional domestic and international travel of approximately 15%.
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 NTM medical strategies and tactics in alignment with the corporate objectives, brand plan, and Japan Medical Affairs Plan.
- Lead the development and implementation of the Japan Medical Affairs Plan, ensuring activities are delivered on scope, on time, on budget, and in compliance with applicable requirements.
- Facilitate scientific exchange with healthcare professionals, scientific leaders, medical societies, government authorities, and other external stakeholders.
- Conduct competitive intelligence and translate medical, scientific, and business insights into strategy and execution.
- Lead local and global medical, commercial, grant, and medical information review and governance processes.
- Support clinical development, regulatory submissions, clinical site and investigator assessment, patient recruitment, pharmacovigilance, and product quality surveillance.
Requirements
- 10–15 years of successful Medical or Scientific Affairs experience in a pharmaceutical or biotechnology company in Japan in a global setting.
- Experience managing cross-functional teams comprising senior medical or scientific experts and operational or administrative professionals.
- Experience with IND and NDA processes in Japan, NHI pricing negotiation, product launches, and pharmaceutical lifecycle management is highly desired.
- Strong knowledge of pharmaceutical research and development, manufacturing, commercialization, compliance, and the clinical and regulatory landscape in Japan.
- Native-level Japanese and high-level business English fluency are required.
- A license to practice medicine in Japan is required for the in-house medical expert responsibilities.
Nice to have
- Experience in pulmonary, infectious, cardiovascular, rare, or neglected diseases.
- Experience supporting clinical development strategy and engagement with PMDA and MHLW.
Culture & Benefits
- Flexible working hours and vacation programs supporting work-life balance.
- Retirement, equity compensation, and employee stock purchase plan opportunities.
- Internal, external, LinkedIn Learning, and role-specific professional development programs.
- AI-enabled learning tools and digital assistant access to internal resources.
- Hybrid work environment with technology and IT support for collaboration across locations and time zones.
- Global recognition programs and employee resource group activities.
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