Rakuten Medical, Inc., is a privately funded, clinical stage Biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Medical has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Medical 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 Medical is currently sponsoring a global Phase 3 multicenter clinical study 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 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.
The Supply Chain Planner position is a key role within our strategic plan for Global Supply Chain management. Excellent organizational skills, ability to balance short term priorities and exceptional information analysis skills are a necessity.
As a member of the Supply Chain group, the Supply Chain planner will act as the interface between the Supply Chain, Clinical Operations and Manufacturing groups to ensure timely availability of finished drug products and matching placebos for use in clinical studies. He/She will represent Supply Chain in all relevant Clinical Study meetings and work with Clinical Operations to build clinical forecast & supply plans. This role also monitors inventory levels and other supply risks and provides feedback to the Clinical Operations team regarding expiry and re-supply.
Key Duties and Responsibilities
- Work proactively to align with Clinical Operations/Study teams to help create forecast for each study and program including enrollment rate
- Act as the subject matter expert for clinical trial supply during regulatory inspections
- Help develop an Inventory strategy per program, study and region
- Monitor regularly drug expiry, and the appropriate inventory re-supply
- Provide monitoring of enrollment, drop-out rates and actual supply needs; ensure continuous reassessment of project needs
- Drive label creation and approvals process, including translations for all countries
- Review regularly budget and spending for relevant studies
- Support regulatory filings including IND submission information, and audits from all health agencies
- Interface with members of Clinical Operations to provide and obtain information and to ensure on time delivery of products
- Maintain strong working relationships and communications with Clinical Operations, manufacturing, key suppliers, Program Management, Finance and other stakeholders to develop supply plans
- Proactively report supply risk, product and material availability issues
- Coordinate with Master scheduler, to ensure adherence to plan, inventory replenishment
- Supplier Management: RFQ, Cost saving initiatives, Negotiations, Supplier relationship/evaluation
- Participate and contribute to supply chain metrics, S&OP (Sales & Operations Planning) process
- Complete special projects and assignments as requested
- This job can require up to 15% travel per year
Desired Education, Skills, and Experience
- BA/BS in a Supply Chain, Operations or scientific field
- Minimum 5 years of experience in Supply Chain Management
- APICS CPIM, CSCP or related certifications is a plus
- Ability to effectively interact with all levels of internal and external management, including CROs
- Demonstrated excellence in project management and managing, tracking, and measuring project progress
- Clinical Supply management experience using contract manufacturing companies strongly preferred
- Work experience must include some of the following: Forecasting, Supply planning, Optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, MRP
- Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP)
- A track record of successfully managing multiple projects within a cGMP related environment
- Ability to manage timelines and prioritize task execution based on business need
- Possesses excellent organizational, project management, technical, problem solving and communication (written & verbal) skills
- Ability to think both strategically and tactically with exceptional attention to detail
- Demonstrated ability to manage multiple high-priority projects concurrently in an often changing environment
- Able to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule
We 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.
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