Sr. Manager, Business Operations Lead

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 Business Operations Lead is responsible for developing study and project level financial budgets, forecasts, and variance analysis for the life of each study; provide project portfolio and scenario planning and analysis; provide vendor and site financial analysis; and develop and implement data analysis systems and tools.  Key responsibilities in this group focus on Clinical Portfolio Financial Management, Vendor and Site Financial Management and Data Analytics. Key Deliverables include Quarterly Forecast, Annual Budget, Long-Range Plan, Governance budget presentations for Corporate Deliverables.

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.
•    Lead financial transparency and accountability in vendor contracting. 
•    Understand savings and/or cost increases resulting from changes in Procurement strategy, contracting, and/or clinical assumptions. 
•    Contribute to the successful collaboration of Business Operations with Key Stakeholders to collect key assumptions required for the development of clinical study contracts and associated budgets.  
•    Support the financial oversight of clinical vendors, including advising key stakeholders of trends and potential financial risks, as well as reviewing financial information for quarterly Executive Oversight Meetings.
•    Participate in the implementation of the Study Financial Management platform to improve financial management and forecasting of study costs for vendor contract management and vendor oversight.
•    Coordinate and support the vendor contract financial management process to meet internal financial reporting requirements.  
•    Support the creation and maintenance of clinical financial models including monthly due-diligence activities e.g., assumption review, PO sweep, contract review, vendor forecast review, as per department processes. 
•    Support the creation, analysis of Study / Project forecasting and variance analysis reports for Key Stakeholders for assigned projects and studies; participate in review meetings with Key Stakeholders and Finance; ensure that suggested changes are accurately tracked, (e.g., change log), incorporated in the clinical financial models and communicated back to the Key Stakeholders Central point of contact for the financial management of clinical portfolio external costs.

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. 
•    Analyze new vendor RFPs, or vendor change orders for impact on budget, and for reasonableness as compared to past/present similar work orders and business requirements.
•    Produce a quantitative and qualitative analysis for new contracts and change orders.

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