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 Associate Director (AD), Medical Affairs is a professional with scientific, clinical and therapeutic area expertise responsible for providing medical support for Rakuten Aspyrian products and compounds in development.  He/she is responsible for the execution of medical affairs activities including medical information, providing scientific review for medical and promotional materials, and managing Investigator initiated research (IIRs)/collaborative research proposals, advisory boards and expanded access program(s). 

• Build and manage the medical information capabilities for Rakuten Aspyrian

• 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

• Serve as medical affairs reviewer for promotional  and non-promotional scientific materials

• 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 Aspyrian 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

• Other duties as assigned

• Advanced degree: PhD, PharmD, or MD

• Minimum 8 years of relevant experience in a pharmaceutical company including a minimum of 6 years’ experience in medical affairs

• Disciplinary expertise in oncology is strongly preferred

• Prior experience with leading/managing medical Information function

• Medical and promotional materials review, and expert knowledge of pharmaceutical medical/promotional regulations and standards is required

• Prior management of IIRs/Collaborative research initiatives is required

• Experience with expanded access programs is preferred

• Prior experience in the planning and implementation of advisory boards is required

• Excellent communication, written, verbal and presentation skills

• Proven ability to review, interpret and present complex scientific data

• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker. Ability to multi-task and shift priorities quickly while working under tight deadlines.

• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction

• Solid ability to foster and maintain strong relations with internal and external customers including investigators and KOLs

• Demonstrated leadership skills

• Must be committed to full compliance with all company SOPs, regulatory requirements, and applicable laws including PhRMA guidelines.

• Proven understanding of the drug development process and prior experience in the pharmaceutical industry

• Proficient with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems 

• Excellent communication, time management and project planning skills

Travel Requirements:

• ~25%