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.
- Effectively manage/oversee both investigational drug and device supply chain for assigned clinical studies, including budget forecasting, sourcing, forecasting, and import/export activities
- Implement and manage IXRS/IRT systems for assigned clinical studies
- Manage supply depots in global clinical trials for inventory, distribution, expiry management, returns, and destruction
- Manage calibration and service calendars for devices
- Develop metrics to monitor and analyze clinical supply chain effectiveness
- In collaboration with QA and the Sr. Manager of Clinical Supply Chain, write and review department Standard Operating Procedures (SOPs), as warranted to support good Quality practices
- Other duties as assigned
- Bachelors or Masters degree in the Life Sciences, Supply Chain Management, Industrial Engineering, or related field
- Minimum 5 years of experience in clinical supply chain management
- Demonstrated ability to work independently and with cross-functional teams, including Clinical Supply Chain, Clinical Operations, CMC, Regulatory, Quality, and Finance teams
- Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies
- Strong organizational and project management skills, including ability to multitask and organize/track information
- Previous experience with combination drug-device studies, and/or global clinical trial experience a plus
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.