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.
- Ensure clinical processes are conducted in accordance with applicable regulations and guidances
- QA and QC review of clinical documents, publication and presentation materials and clinical sections of regulatory submissions
- Develops, performs and manages ongoing Clinical QA activities
- Ensure maintenance and audit of clinical trial documents, both from CROs and internal, as appropriate, including Trial Master Files
- Assist in identifying non-conformances during clinical trial conduct, provides risk mitigation strategies and feedback and recommendations to facilitate ongoing process improvement.
- Management of CAPA plans and site audits as warranted
- Assist in the writing and review of Clinical Quality-related SOPs
- Participate in cross-functional meetings and act as the point person for clinical quality activities
- Other duties as assigned
- Bachelor’s degree or equivalent in the life sciences or related field
- Minimum 7 years related clinical quality experience in a similar environment
- Develop and maintain GCP/ICH compliant processes
- Demonstrated ability to work independently and with cross-functional teams, including Clinical, Medical,
- Data Management, Quality, Regulatory and CMC
- Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA/QC review of data, clinical and medical documents
- Previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience is a plus
- Strong organizational and project management skills, including ability to multitask and organize/track information
- Willingness to travel, at times, up to 20-30%