Sr Manager Business Operations Lead

Kyowa Kirin is a fastgrowing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japanbased 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 LongRange 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 tradeoffs 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 duediligence 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/crossportfolio)
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.
Ensure vendors are trained appropriately to provide accurate and timely financial data as per requirements.
Ensure vendor adheres to submission timelines and establish reporting process.
Partners with and Project Team in the financial oversight of clinical vendors including reviewing financial information advising Oversight Team Members of trends and potential contract financial risks providing content to Financial Vendor meetings as required and attending meetings for assigned vendors

Requirements:

Education
Bachelors degree in life sciences business administration or a related field; advanced degree preferred.

Experience
Minimum of eight 8 years of experience in the life science industry working clinical trial management with increasing responsibilities including a focus on business operations.

Technical Skills
Proficiency in Microsoft Office Suite and clinical trial management systems and analytics tools.
Contributing to crossfunctional decisions regarding financial impact of vendor contracting.
Contributing to an organizationwide view on how financial and accounting decisions are made and the impact on corporate finance reporting and executive decisionmaking.
Embracing a culture that values the importance of process technology and performance measurement to drive improvement.
Demonstrating robust knowledge of GCP guidelines and their impact on each stage of the trial (startup through closeout) and actively contributing to discussions with vendors and project team on GCP compliance issues.
Lead scenario analyses and identifying financial implications of project and vendor decisions.
Understanding global competitive environment for executing clinical project in a therapeutic area.
Proactively investigating and resolving complex contracting and budgeting issues.

NonTechnical Skills
Strong negotiation contract management and project management skills.
Excellent communication and interpersonal skills with the ability to build and maintain relationships with external partners and internal stakeholders.
Ability to manage multiple projects and priorities in a fastpaced environment.
Has a passion for personal learning and development to be able to grow with the company.
Cultural sensitivity and ability to develop consensus within a multinational organization.

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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