Associate Director, Business Operations Lead
About The Position
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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario. Summary: The Business Operations Lead (BOL) is responsible for developing and managing project financial budgets, forecasts, and variance analysis for the life of each study. The BOL provides scenario planning analysis, vendor financial analysis, and implements data analysis tools and insights. The BOL is responsible for providing enterprise-wide financial leadership, strategic planning, and governance support across all GDO functions, including Clinical Operations, Data Management, Biostatistics, Non-clinical Development, Biomarkers, Clinical Pharmacology, Pharmacometrics, and other functions involved in Development. Key Deliverables include Monthly Financial Reporting and Forecasting, Annual Budgets, Long-Range Planning, and budget presentations to support Governance and other Executive Financial Deliverables. The BOL is accountable for ensuring financial transparency, consistency, and governance across internal functions and external vendors, while driving scalable financial processes, analytics, and systems to support GDO strategy and execution.
Requirements
- Bachelor’s degree in life sciences, business administration, or closely related discipline; advanced degree preferred.
- Minimum of seven (7) years in FP&A, R&D finance, or business operations within the biopharmaceutical or life sciences industry, including ownership of complex, multi-million-dollar clinical program budgets.
- Demonstrated expertise in clinical trial financial management, including forecasting, accruals, variance analysis, and vendor/CRO budget oversight across Phase I–IV studies.
- Experience partnering cross-functionally with Clinical Operations, Data Management, Biostatistics, Non-clinical Development, Biomarkers, Clinical Pharmacology, Pharmacometrics, and other Development team.
- Advanced expertise in development budgeting, forecasting, and portfolio financial management.
- Strong understanding of end-to-end drug development, including clinical and non-clinical functions.
- Ability to connect operational and scientific decisions to corporate finance, accounting, and reporting impacts.
- Advanced scenario planning and financial modeling capabilities.
- Experience implementing or optimizing financial systems and analytics tools.
Responsibilities
- Own end-to-end financial oversight for study, program, and portfolio-level budgets, forecasts, and variance analyses across all GDO functions, ensuring alignment of functional plans, development strategies, vendor models, and financial projections.
- Lead financial governance and scenario planning, including assumption management, scope and change control, interdependency management, and development of financial scenarios to support Project Teams, GDO leadership, governance forums, and strategic decision-making.
- Provide senior financial leadership for vendor strategy and oversight across all GDO-supported activities, including CROs and specialty vendors, ensuring transparency, accountability, and alignment between procurement strategy, contracting models, and financial outcomes.
- Establish and enforce vendor financial management standards, including financial reporting requirements, review processes, data quality expectations, submission timelines, and escalation pathways; serve as the primary financial point of contact and escalation lead for complex vendor financial issues.
- Oversee vendor financial performance and analytics, including validation of vendor financial reporting, variance analyses, identification of trends, risks, and opportunities, and communication of insights to Project Teams and oversight committees.
- Support vendor selection, contracting, and change management, including spend analyses, bid comparisons, benchmarking, financial modeling, and quantitative and qualitative evaluation of new contracts, RFPs, and change orders to inform negotiation, governance, and investment decisions. Produce a quantitative and qualitative analysis for new contracts and change orders.
- Act as the primary vendor financial point of contact for communicating Kyowa Kirin processes and best practices related to vendor contract financial management. Serves as point of escalation for unresolved vendor financial issues. Ensure vendors are trained appropriately to provide accurate and timely financial data, as per requirements.
- Lead end-to-end financial strategy for a portfolio of development programs spanning all GDO functions.
- Integrate financial assumptions, risks, and forecasts across Project Leadership, Clinical Operations, Data Management, Biostatistics, Non-clinical, Biomarkers, Clinical Pharmacology, and Pharmacometrics.
- Serve as a trusted financial advisor to Project Teams, Functional Heads, and GDO Leadership.
- Support enterprise decision-making through portfolio trade-off analyses, scenario planning, and investment prioritization.
- Translate complex cross-functional financial data into clear executive-level insights for governance forums.
- Ensure consistency and rigor in financial decision-making across therapeutic areas and programs
- Lead or significantly contribute to the design, implementation, and optimization of GDO financial management systems and analytics platforms.
- Drive standardization and scalability of financial methodologies, forecasting approaches, and reporting processes across all GDO functions.
- Champion data-driven decision-making and continuous improvement in financial transparency and efficiency.
- Support development and refinement of SOPs, governance frameworks, and best practices.
- Utilize the information in the Vendor Financial Reporting Package to update clinical financial models, as applicable.
Benefits
- 401K with company match
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Life & Disability Insurance
- Concierge Services
- Long Term Incentive Program (subject to job level and performance)
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
