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 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.


Position Summary

The Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the clinical development programs, from start-up through completion of clinical trials, with inspection readiness in mind throughout.   The ideal candidate will advise on company clinical quality strategy and quality management systems and interact directly with the clinical, regulatory and quality teams.  The ideal candidate will have at least 10 years of experience in clinical quality and process improvement and at least one year of clinical auditing experience.  The candidate will have an excellent working knowledge of Good Clinical Practices, and quality requirements and regulations in Japan (PMDA) and other Asia Pacific countries, such as Korea and Taiwan.  In addition, knowledge of other international regulations (e.g. US FDA, EU, ICH E6) and Good Clinical Practices are desirable.


Key Duties and Responsibilities 

Provide strategic and operational leadership in the planning and executing of Clinical GCP Quality activities to support companywide and clinical development/clinical trial Quality activities

Maintains current knowledge of ever-changing clinical quality guidance and regulations

Excellent communication and people skills to ensure a cohesive, collaborative teamwork 

Demonstrated ability to implement and collaboratively drive company initiatives and policies

Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections by regulatory agencies (domestic and international) highly preferred

Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close) 

Successfully demonstrates ability to both conduct and manage site and/or vendor audits as well as direct and guide audit follow-up actions

Establish Quality and Cross-Functional SOPs and processes, and associated document controls

Serve as local document management system administrator

Manage and mentor direct reports

Participate in cross-functional meetings between departments and Quality teams

Other duties as assigned


Desired Education, Skills, and Experience

B.S. Degree in life sciences with advanced degree in a scientific discipline preferred

Minimum of 6 years direct experience in GCP Quality Assurance and/or GCP Compliance

Minimum of two years of GCP auditing (e.g. clinical site and/or clinical vendor) experience preferred

Demonstrated ability to work with various 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 review of clinical documents

Previous experience with oncology (head and neck cancer), combination drug-device studies, and/or global clinical trial experience is a plus

Pharmacovigilance/Safety QA experience a plus

Electronic TMF, document, quality, and learning management systems experience

Strong organizational and project management skills

Professional working proficiency (IRL scale) or above in Japanese and English

Willingness to travel up to 30%, but at times may be higher based on business needs


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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