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 Field Clinical Trainers will be key members of the Clinical Operations team with responsibilities to train physicians and support staff to properly perform Aspyrian drug product infusions and photoimmunotherapy (PIT) procedures.The Field Clinical Trainer will also provide feedback to clinical and R&D regarding product performance. The Field Clinical Trainer may train site personnel with study-related data collection and/or documentation practices.

The ideal candidate will have a RN, PA, NP or other relevant clinical license with experience in surgical, interventional radiology, intensive care or radiation oncology settings, and with prior experience in an educator or trainer capacity.Additionally, a working knowledge of drug development process, GCP, ICH guidelines and EMA regulations is highly desirable.

The Field Clinical Trainer may be located anywhere in Europe within a reasonable distance of a major airport, and will report to the Associate Medical Director. This position will require the ability and willingness to travel extensively up to 70% time, within Europe as clinical study enrollment and caseload activities dictate.


Key Duties and Responsibilities

  • Educate, inform and observe doctors in the proper application of the Rakuten Aspyrian photoimmunotherapy treatment in patients
  • Provide training to physicians and support staff on proper drug product storage, handling, preparation, and infusion procedure following protocol design
  • Educate and inform doctors, nurses, and appropriate staff personnel of the proper use and maintenance of Rakuten Aspyrian products
  • Assessment and monitoring of physicians’ skill levels with Aspyrian products.Identify and perform retraining, as applicable or requested
  • Preparation of training materials (e.g., presentation slides, reference guides)
  • Provide clinical and technical feedback regarding device performance, user ergonomics and suggest design improvements.Similarly, identify improvements in procedure techniques that can reduce time and/or improve ease of use
  • Become the go-to expert in the company on study product infusion and PIT procedures
  • Assist and support Clinical Operations in ensuring protocol compliance
  • Assist and support site personnel with study-related data collection or documentation practices
  • Rakuten Aspyrian is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities.
  • Other duties as assigned


Desired Education, Skills and Experience

  • RN, PA, NP or other relevant clinical certification, with active license (as appropriate) preferred
  • Surgical, Intensive Care, Interventional Radiology, Emergency Room and/or Oncology experience desired
  • BSN, BS in Biomedical Engineering or Health Sciences degree desired
  • Minimum 3-5 years related pharmaceutical industry experience
  • Prior demonstrated experience in an educator/trainer capacity
  • Strong medical and anatomic knowledge
  • Ability to work independently
  • Excellent oral and written communication skills
  • Excellent interpersonal and team building skills
  • Able to quickly build rapport, credibility, and trust with physicians and operating room, radiology and infusion center staff
  • Ability to process and prioritize sensitive complex information and problem solve with good judgment under time constrains
  • Decisive, able to give procedural coaching/direction calmly and assertively
  • Understanding of regulatory guidelines for adverse event reporting for serious/unexpected events
  • Understanding of guidelines for reporting device malfunctions
  • Working knowledge of Federal Guidelines, Good Clinical Practices, drug development process, and conduct of clinical studies


Physical demands:

  • Must be able to lift up to 50 pounds on occasion
  • Must be willing and able to travel up to 70% of the time


We are proud to offer a competitive compensation plan with an excellent benefits package.

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.

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