Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ technology platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Illuminox therapies have not yet been approved as safe or effective by any regulatory authority.
The company’s first investigational product developed on the Illuminox platform, ASP-1929, has achieved Fast Track designation from the FDA and Sakigake Designation from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 6 locations in 5 countries, Japan, the Netherlands, Germany and Taiwan. For more information, visit www.rakuten-med.com.
The Director/Senior Director, Global Supply Chain is responsible for managing end to end supply chain related activities to ensure clinical supply & launch readiness in U.S., Japan, APAC, and EU. The ideal candidate will have 10+ years of experience in clinical & commercial supply chain management, with global experience preferred.
The Director/Senior Director, Global Supply Chain will manage the P&L Contract Manufacturing Organizations (CMOs) and depots for the storage and distribution of clinical supply globally. In addition, this individual will work closely with regional supply chain teams to manage secondary packaging vendor relationships in order to ensure that supplies are ready to support commercialization timelines. The candidate will oversee all shipping and global logistics activities to ensure that supplies are delivered in a timely manner to commercial customers.
The Director/Senior Director, Global Supply Chain will serve as the lead of the Global Supply Chain team and will report to the CTO. Rakuten Medical is looking for someone who is willing to grow with our company and willing to meet the challenges.
Key Duties and Responsibilities
- Oversee the vendor selection process to support secondary packaging and global distribution needs
- Oversee labeling/packaging activities performed by the CMO to ensure that supplies are packaged and labeled to support commercial launch
- Effectively manage both clinical & commercial drug packaging and device supply chain, including budgeting, sourcing, forecasting, and import/export activities
- Manage clinical depots for inventory, distribution, expiry management, returns, and destruction
- Collaborate with Marketing, Regulatory, and Quality to support clinical supply & commercial launch
- Support projects and process improvement efforts related to clinical & commercial supply chain
- Support regulatory inspections for commercial packaging, warehouses, storage locations, and distribution centers
- In collaboration with QA, write and review department Standard Operating Procedures (SOPs), as warranted to support good Quality practices
- Develop metrics to monitor and analyze clinical & commercial supply chain effectiveness
- Oversee IRT systems for clinical distribution
- Support system / ERP implementation for supply chain
- Develop & implement the S&OP process for the company
- Other duties as assigned
Desired Education, Skills and Experience
- Bachelors or Master’s degree in the Life Sciences, Supply Chain Management, Industrial Engineering, or related field
- Minimum 10 years of experience in commercial supply chain management
- Demonstrated ability to work independently and with cross-functional teams, including Regulatory, Quality, Sales, Marketing, and Finance teams
- Proficiency in GMP processes, CFRs, commercial labeling, and import/export requirements for commercial supplies
- Strong organizational and project management skills, including ability to multitask and organize/track information
- Previous experience with combination drug-device 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 Medical 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.