Sr. Manager, Business Operations Lead

Posted 12 Days Ago
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Princeton, NJ
Senior level
Pharmaceutical
The Role
The role involves financial management of clinical projects, vendor contracting, budgeting, forecasting, and analysis, ensuring effective collaboration with stakeholders.
Summary Generated by Built In

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 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
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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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Top Skills

Analytics Tools
Clinical Trial Management Systems
Microsoft Office Suite
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The Company
HQ: Bedminster, NJ
463 Employees
On-site Workplace

What We Do

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. We work on some of the hardest to treat diseases where need is high, and potential for life-changing impact is possible.

The North America organization includes three offices in New Jersey and California that focus on drug discovery, product development, and commercialization. Together, we work as a collaborative team to understand clinical needs and advance innovations that have a profound impact on patient lives.

Our growth in North America relies on entrepreneurial team players who are willing to share their expertise and ideas in an environment that prioritizes innovation, diversity, integrity and “wa.” Each person plays a significant role in shaping the work we do and the results we deliver.

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