Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Summary:
The Global Clinical Business Operations (GCBO) sub-function of Global Clinical Operation provides industry best practice operational support for the conduct of Kyowa Kirin’s global clinical trials, including clinical financial spend analysis and management, vendor contract and clinical site budgets management. The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor and site spend, assists with financial and resource projections across clinical projects and studies, manages the development, negotiation and execution of clinical site budgets and vendor contracts, as well as facilitates effective clinical vendor oversight.
Essential Functions:
Vendor and Site Financial Modeling and Management- (Budget, Forecasting and Analytics)
• Develop financial scenarios and analyses in support of Project and Study Teams, and GDO Management strategy development and planning.
• Support the financial management of the clinical portfolio external costs by providing financial scenarios for expense trade-offs, identifying savings and/or cost increases resulting from changes in Procurement strategy, contracting, and/or clinical assumptions.
• Central point of contact for the financial management of clinical portfolio external costs for assigned studies.
Vendor selection and change order management
• Partner with Procurement in the due diligence process for CRO new bids and change orders.
• Support the vendor selection process by performing CRO spend analyses and CRO bid comparisons, including developing financial models (e.g. Clear Trial, Grant Plan, Clinical Maestro), as required
• Benchmark potential new studies and potential changes to a study for governance and scenario planning purposes.
Vendor financial validation and reporting (study specific)
• Review and validate the accuracy of the vendor financial reporting package with Key Stakeholders
• Ensure timely escalation and resolution of any identified discrepancies during the review process
• Utilize the information in the Vendor Financial Reporting Package to update clinical financial models, as applicable.
Vendor financial performance, escalation, and processes (vendor specific/cross-portfolio)
• Establish vendor financial reporting requirements (e.g. Vendor Financial Reporting Package- FSR and Monthly Review Process) and communicate Kyowa Kirin expectations to the vendors.
• Performs vendor portfolio financial analyses, such as variance analyses to contract budget and other vendor financial metrics.
• Act as the primary vendor point of contact for communicating Kyowa Kirin processes and best practices related to clinical vendor contract financial management. Serves as point of escalation for unresolved vendor financial issues by Clinical Portfolio Financial Management or study teams.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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