Improve cell-product manufacturing and analytical methods, manage outsourced production and testing, and support regulatory submissions and technology transfer.
About this role
SanBio is hiring a director of clinical science and medical affairs to connect development evidence with medical practice. The director owns the department’s scientific strategy and interpretation while trial operations and formal regulatory submission functions sit with other teams.
Responsibilities include clinical plans, scientific review of protocols and clinical CTD content, authority consultation strategy, integrated evidence, publications, real-world evidence and medical-science liaison activity. The role also governs compliance, staffing, development, budgets and departmental quality.
Applicants need twelve years in relevant healthcare industries, seven years in clinical science or medical affairs, leadership of development plans, authority consultations and clinical CTD preparation, three years of people management, and business English. Specialist degrees are preferred. Salary is undisclosed. Tokyo office attendance is expected around three or four days weekly initially and two or three later, with individual discussion possible.
This is an AI-generated summary of the employer's original posting — details can be incomplete, out of date or simply wrong. Always confirm everything on the official posting before applying.
Similar jobs
Build and operate quality systems for cell-therapy products, lead audits and corrective actions, manage product quality and support regulatory and supplier interactions.
Create and deliver tailored IT training, manuals and learning scenarios that help employees adopt new systems, use office tools and improve security awareness.
Perform captain and related flight duties after joining Skymark, bringing Japanese airline command experience and the required aviation credentials and flight hours.
Complete company training toward B737 first-officer appointment, then operate scheduled flights using prior Japanese airline experience and required aviation licences.
Develop supplement formulations, coordinate prototypes and manufacturing scale-up, and prepare scientific reviews and function-claim filings with partner companies.