• 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.