Company Profile

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 for ASP-1929 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 of ASP-1929 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.

Position Summary

The Sr. Manager/Associate Director (AD) of 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. The Sr. Manager/AD is responsible for the execution of medical affairs activities including medical information, scientific review for medical and promotional materials, and managing Investigator initiated research (IIRs)/collaborative research proposals and expanded access program(s).

Key Duties and Responsibilities

  • Develop and communicate appropriate, quality, compliant and timely responses to 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 materials and non-promotional scientific materials
  • Support the management of IIR/Collaboration research proposals and expanded access/compassionate use program(s)
  • Plan and organize medical-scientific events, scientific congresses, symposia, advisory boards (e.g. 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
  • Assist with the creation 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

Desired Education, Skills and Experience

  • Advanced degree, e.g. PhD, PharmD, or MD required
  • Minimum 3-6 years of relevant experience in a pharmaceutical or biotechnology company including a minimum of 2-3 years of experience in medical affairs required
  • Promotional materials review committee experience and expert knowledge of pharmaceutical promotional regulations and standards is required
  • Medical Information experience is required
  • Prior involvement with IIRs/Collaborative research and Expanded access preferred
  • Experience in planning and implementation of advisory board preferred
  • Excellent communication, written, verbal and presentation skills
  • Proven ability to review, interpret and present complex scientific data
  • Analytical and problem-solving skills; detail-oriented, 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
  • Experience in working closely with KOLs and investigators
  • Demonstrated leadership skills
  • Must be committed to full compliance with all company SOPs, regulatory requirements, and applicable laws including PhRMA guidelines
  • Proficient with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems
  • Excellent time management and project planning skills
  • Disciplinary expertise in oncology preferred
  • Up to 30% travel

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

This position has been filled. Would you like to see our other open positions?