Sr. Manager, Business Operations Lead

Kyowa Kirin, Inc.- U.S.; Princeton (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Business Operations Lead to oversee financial management in clinical trials. This role involves developing budgets, forecasts, and variance analyses while ensuring financial transparency and accountability with vendors. The ideal candidate will have a strong background in life sciences and project management, with a focus on enhancing operational efficiency. Join a forward-thinking company that values innovation and collaboration, and make a significant impact in the pharmaceutical industry by delivering critical financial insights that drive successful clinical outcomes.

Qualifications

• 8+ years in life sciences with clinical trial management experience.
• Bachelor's degree required; advanced degree preferred.

Responsibilities

• Develop financial budgets and forecasts for clinical studies.
• Manage vendor financial models and ensure compliance.
• Coordinate financial reporting and vendor contract management.

Skills

Financial Analysis

Negotiation Skills

Project Management

Communication Skills

Data Analysis

GCP Compliance Knowledge

Education

Bachelor's degree in life sciences

Advanced degree in related field

Tools

Microsoft Office Suite

Clinical Trial Management Systems

Analytics Tools

Job description

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.

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 Monthly Review Process) and communicate Kyowa Kirin expectations to the vendors.
• Perform 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.
• Partner with 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
Bachelor’s 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 cross-functional decisions regarding financial impact of vendor contracting.
• Contributing to an organization-wide view on how financial and accounting decisions are made and the impact on corporate finance, reporting, and executive decision-making.
• 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 (start-up through close-out) 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.

Non-Technical 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 fast-paced 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.