Manager, Technical Operations and Supply Chain Management

<div class="content-intro"><p><strong>Company Profile</strong><span data-ccp-props="{}">&nbsp;</span></p> <p>Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.</p> <p>Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally 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.</p> <p>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 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit <a href="http://www.rakuten-med.com">www.rakuten-med.com</a>.&nbsp;&nbsp;</p></div><p><strong>Key Duties and Responsibilities</strong><strong>&nbsp;</strong></p> <p>Collaborate with global clinical teams (Clinical Operations, CMC, Quality Assurance, Regulatory, etc.) and network of Clinical Development and Manufacturing Organizations to oversee end-to-end supply chain activities from phase 1-3 and IIT trials. Leads and manages clinical packaging and labeling operations / Investigational Drug, Standard of Care Drug and Medical Devices, drive clinical label creation and approvals process, including translations for applicable countries. Lead end-to-end supply chain network set-up for new and upcoming global clinical trials. Develop Supply Strategies and Inventory optimization plans per program, protocol design and region. Design, Implementation and UAT of Interactive Response Technology (IRT/IxRS) for multi-arm drug-device combination trials. Develop, implement, and update Supply Chain SOPs and Work Instructions. Co-develop device and pharmacy manual. Manage Temperature excursions, CAPA, SCARs and other quality events as applicable. Supplier Management: Standard of Care Drug Procurement, RFQ, Vendor Management, Cost saving initiatives, Negotiations, Supplier relationship/evaluation. Quarterly review of budgets vs actual spend for active studies. Provide Supply Chain support for regulatory filings including IND submission information, Import/Export Licenses filing and audits from all health agencies. Proactively report supply risk, product and material availability issues. Participate in and contribute to supply chain metrics, S&amp;OP (Sales &amp; Operations Plann