Rakuten Medical

Clinical Research

• 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 event.
• 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 external stakeholders.
• Serve as medical affairs reviewer for promotional and non-promotional scientific materials.
• Build and manage the medical information capabilities for Rakuten Medical. Develop and communicate appropriate, quality, compliant, and timely responses for Medical Information requests.
• Create and maintain a product knowledge database including, but not limited to, written standard response letters and FAQ documents that are scientifically accurate and fair-balanced.
• Other duties as assigned.
• May be required to travel up to 30% of the time regionally or international based on project needs.

Clinical Scientist