Clinical Quality Manager
We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company located in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.
We are supported by investors that have the commitment to build a long-term company that integrates research, development, and commercialization of cutting-edge cancer therapies with the aim to transform cancer treatments. Our mission is “CONQUERING Cancer. For LIFE.”
We are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product is planned to initiate Phase 3 pivotal clinical testing to treat terminal cancer patients. This is a first in class product with unique pharmacological activity and with the potential to have a broad impact in cancer treatment. 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.
The Clinical Quality Manager will be responsible to manage various clinical quality related activities in coordination with clinical team leadership. The ideal candidate will have 7 + years of experience in clinical quality and process improvement. The candidate will have broad working knowledge of the drug development process. Global clinical trial quality experience is a plus.
Key Duties and Responsibilities
- 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
Desired Education, Skills, and Experience
- 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%
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.