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 Director/Sr. 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 15+ years of experience in clinical quality and process improvement. The candidate will have an excellent working knowledge of Good Clinical Practices, and quality requirements and regulations in Japan and other Asia Pacific countries, such as Korea and Taiwan. In addition, knowledge of other international regulations (e.g. US FDA, EU) 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
• Direct 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 15 years of pharmaceutical and/or biotech experience with at least 12 years direct experience in Quality Assurance, GCP and Compliance
• 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 highly preferred
• GMP 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 20-30%, but at times may be higher based on business needs
We are proud to offer a competitive compensation plan with an excellent benefits package 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.