We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company headquartered 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 will advance into 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. 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.
- 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 SOPs and processes
- Manage and mentor direct reports
- Participate in cross-functional meetings between departments and Quality teams
- Other duties as assigned
- 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
- Strong organizational and project management skills
- 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.