Clinical Scientist

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer – and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients.

This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India.

For more information, visit www.rakuten‑

The Clinical Scientist will report to the Executive Medical Director and be a key member of the Clinical Development team with responsibilities to provide scientific support for clinical development activities from clinical proof of concept to trial design and subsequent execution of the study protocol to ensure a successful clinical study. Collaboration with R&D, program management, clinical operations, biostatistics, and data management is essential.

Additionally, this role will support the development of key scientific external relationships with key opinion leaders and provide clinical input into safety and regulatory interactions. Beyond clinical development, responsibilities include executing medical affairs activities, such as providing medical information, conducting scientific review for medical and promotional materials, oversight of investigator‑initiated research (IIRs) and collaborative research proposals, overseeing expanded access programs, and leading key scientific exchange activities, including conferences, scientific advisory board meetings, consulting meetings, and publication projects for Rakuten Medical.

A working knowledge of drug development process, GCP, ICH guidelines and TFDA regulations is highly desirable.

• Contribute to the clinical strategy and creation of the clinical development plans for various oncology indications, working as part of an integrated drug development team.
• Provide scientific input to protocol development and definition of efficacy and safety endpoints for proof of concept, Phase I, Phase II, and III clinical trials.
• Collaborate with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assure appropriate data review and accurate data reporting.
• Prepare data and contribute to scientific publications including posters, abstracts and manuscripts.
• Support the clinical team with the development of program documents, including the clinical sections of various regulatory documents and submissions to support product approvals.
• Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations.
• Present and provide program updates at internal Leadership meetings and external stakeholders events.
• Proactively seek out and recommend process improvements.
• Build and manage the IIR/collaboration research and expanded access/compassionate use program(s).
• Plan, organize and manage medical‑scientific events, symposia, advisory boards (eg. KOL selection, meeting materials, and logistics).
• Represent Rakuten Medical at major scientific meetings and conferences. Staff conference booths and develop meeting reviews/reports as assigned.
• Perform subject‑specific literature reviews to assist the organization in staying abreast of the scientific landscape and developments.
• Create and implement policies, SOPs and work instructions governing the operations of medical affairs to meet all compliance standards and regulations.
• Establish strong collaborative relationships with key internal and…