・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務
The Medical Director / Medical Director & Medical Expert shall demonstrate excellence in science/medicine and operations and assume leadership and subject matter expert (SME) roles for the development and execution of JMA strategies and Japan Medical Affair Plan (MAP) throughout the life cycle of our product(s) and therapeutic/disease area(s).
The individual in this position shall work autonomously and collaboratively with local/global internal stakeholders and external stakeholders and medical/professional societies.
The individual shall keep compliance, quality, speed in mind, and maintain transparency by keeping books and records. This position may have people management responsibility when assigned.
Roles and Responsibilities:
・ Scientific/Medical Excellence: Provide and gain quality information and insights to internal and external stakeholders with in-depth and up-to-date understanding of designated therapeutic areas, diseases, products and technologies.
・ Operational Excellence: Lead, manage and coordinate the planning and implementation of strategies and tactics for day-to-day JMA activities. Ensure that the activities are planned and executed in compliance with applicable laws and regulations, and internal policies, SOPs and requirements.
・ Expert Engagement and Scientific Exchange: Lead, manage/coordinate and facilitate engagement with external stakeholders with integrity. Ensure professional, balanced, fully compliant and productive exchange of scientific/medical information and insights.
・ MAP: In close collaboration with the Therapeutic Area (TA) and Product Medical Director of JMA, manage and coordinate the development, execution and update of MAP in alignment with global / local strategies and tactics.
・ Review and Governance: Manage and coordinate review and decision processes locally, Japan Commercial Review Committee (J-CRC), Japan Grant Review Committee (J-GRC)) and globally.
・ Clinical Development: Support strategy building and planning, including engagement with authorities such as PMDA and MHLW. Support identification and selection of external medical experts. Support Clinical Trial Operations for their assessment of clinical sites and investigators.
Experience and knowledge:
・ Minimum of 5-7 years of experience in Medical/Scientific Affairs in a pharmaceutical/biotechnology company in Japan in a global setting.
・ Solid experience in managing cross-functional team consisting of both medical/scientific experts and operational/administrative professionals.
・ Experience in IND and NDA in Japan, NHI pricing negotiation, product launch excellence and life cycle management of pharmaceutical products in Japan is highly desired.
・ Clinical development or research experience in Japan and/or US/EU is a great plus.
・ Proven record of knowledge and experience in the field of pulmonary, infectious and/or cardiovascular diseases is strongly preferred.
Skills and capabilities:
・ Language: Native-level fluency in Japanese and high-level business fluency in English.
・ Ethics and compliance: Adherence to uncompromising ethical standards. Solid understanding of applicable local and global policies, rules and regulations as well as compliance policies and requirements of the pharmaceutical industry in Japan.
・ Business acumen: Solid understanding of pharmaceutical business, including drug research and development, manufacturing, commercialization.
・ Communication/Presentation: Ability to quickly understand and dialogue on subjects that are at the interface between medicine and policy. Ability to connect science/medicine and unmet medical need to MA strategy. Excellent in disseminating and communicating complex scientific information and data in an impactful while balanced and user-friendly way. Excellent intra-personal and presentation skills (verbal and written, in Japanese and English) with the ability to effectively present ideas, and influence and negotiate with others to achieve desired goals.
・ Must live in Japan.
・ Degree, License:
➢ Master's or higher degree in pharmacology, pharmaceutical, clinical and life science or equivalent field of study is highly preferred. A candidate with the Bachelor's degree will be considered if the candidate has significant MA experience.
➢ Doctoral degree (e.g., MD, PhD) will be considered with the highest priority. Those with a degree in medicine (physician) must possess a presently active license to practice medicine in Japan. A board certification in pulmonology, infectious disease and/or cardiology is highly valued.
➢ Health care providers are highly encouraged to apply.
・ Experience in clinical development and research and/or basic research in overseas is advantageous.
・ A certification in Health Economics and/or ISMPP)as a Medical Publication Professional is valued.
・ Non-smoker (must).
・ Must have an ability to travel (domestic and international) approximately 20% - 30% of time.
Seniority Level: Director
Job Function: Health Care Provider, Other