Rakuten Aspyrian, Inc., is a privately funded, clinical stage Biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform. 

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses. 

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy in patients with other cancer types. 

Given the rapid progression of the clinical studies, we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

The Medical Director, Medical Affairs is responsible for the strategic planning, development and execution of a Medical Affairs Plan. He/she will establish and maintain strong medical and professional relationships with key medical/scientific experts in the oncology field. The Medical Director, Medical Affairs will collaborate and take medical leadership within cross-functional teams.  He/she will be well-versed in the pertinent therapeutic areas of interest to Rakuten Aspyrian and deliver medical and scientific presentations on behalf of the company.  The Medical Director, Medical Affairs is responsible for the review and approval of medical, promotional and educational materials ensuring medical and scientific accuracy. He/she will be actively involved in lifecycle management initiatives.

• Accountable for execution and delivery of the Medical Affairs Plan

• Responsible for the implementation and execution of medical strategies to support lifecycle management and pipeline expansion 

• Drive medical affairs activities (e.g. advisory boards, training, disease initiatives) and generation of data supporting overall product scientific and business strategy

• Function as a medical expert for Rakuten Aspyrian’s therapeutic areas of interest and products; provide expertise within and outside the organization

• Build and maintain strong relationships with KOLs and HCPs in the therapeutic area of interest; commit to ongoing scientific exchange with customers as appropriate in the field and at medical congresses

• Deliver medical and scientific presentations and provide relevant scientific and technical training

• Represents Rakuten Aspyrian at external meetings including investigator meetings, medical advisory boards and scientific conferences

• Medical lead for review/approval of medical and externally-facing materials

• Provide scientific input into publication strategy

• Review manuscripts for publication, abstracts and posters for presentation at scientific meetings

• Represent the medical affairs function on cross-functional integrated teams

• Support and provide medical input on lifecycle management initiatives

• Identifies data gaps that will inform the IIR program and HEOR initiatives

• Proactively stay abreast of recent scientific/medical literature relevant to therapeutics areas of interest; awareness of competitors' development activities 

• Other duties as assigned 

• Medical Degree (M.D.) with in depth understanding and experience in oncology

• Board certification in oncology or comparable training strongly preferred

• 7 + years of medical affairs experience in the pharmaceutical or biotech industry

• Scientific credibility to lead interactions with KOLs, senior leaders and other external parties

• Excellent written, oral communication, analytical and problem-solving stills

• Experience in collaborating with medical, commercial, clinical, regulatory, health outcomes, and other organizational partners

• Proven strategic thinking related to product development and pipelines

• Strong knowledge of FDA/EMA/PMDA requirements, and pharmaceutical clinical development

• Understanding of Phase 1-4 drug development with proven ability to communicate clinical/scientific data, and generate clinical/scientific documents

• Well organized with strong management, leadership, mentoring and motivational skills

• Ability to work independently and thrive in a fast-paced environment

• Travel up to 30%