Associate Director, Clinical Trial Budget Planning & Management
$168.37k - $220.99kLegend Biotech USA, Inc.
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking an Associate Director, Clinical Trial Budget Planning & Management as part of the Clinical team based in Somerset, NJ . Role Overview The Associate Director, Clinical Trial Budget Planning & Management is responsible for enabling the planning, forecasting, tracking, analysis, and financial oversight of clinical operations budgets across the portfolio. This individual will serve as a partner to Clinical Operations Program Leads and Finance to enable accurate trial budget forecasting, vendor budget assessments for cost efficiency, and financial transparency throughout the lifecycle of clinical trials.
The role requires a strong combination of foundational clinical operations knowledge, financial acumen, forecasting expertise, and stakeholder management capabilities. The individual will drive annual budget planning, long-range forecasts for trial budgets, assessing vendor budgets to drive cost efficiency, variance analysis, and ongoing financial performance monitoring to enable cost efficient clinical operations trial delivery. Key Responsibilities Clinical Trial Budget Planning & Forecasting
The role requires a strong combination of foundational clinical operations knowledge, financial acumen, forecasting expertise, and stakeholder management capabilities. The individual will drive annual budget planning, long-range forecasts for trial budgets, assessing vendor budgets to drive cost efficiency, variance analysis, and ongoing financial performance monitoring to enable cost efficient clinical operations trial delivery. Key Responsibilities Clinical Trial Budget Planning & Forecasting
- Collaborate with study Operations Program Leads (OPLs) for development of annual operating budgets, long-range plans, and quarterly forecasts for clinical trial budgets.
- Partner with Clinical Operations and Finance to develop activity-based budget assumptions reflecting efficient labor requirements from vendors (CROs) to support enrollment timelines, site activations, and site monitoring and management strategies.
- Build and maintain detailed trial-level and program-level budget models incorporating planned expenditures, and anticipated timing of spend.
- Develop multi-year forecasts and scenario analyses to support portfolio planning and strategic decision making.
- Evaluate budget impacts associated with protocol amendments, study expansions, country additions, enrollment changes, and vendor scope modifications.
- Support vendor engagement strategy discussions through financial analyses and budget recommendations.
- Maintain visibility into actual spend, committed spend, accruals, and forecasted expenditures across multiple clinical programs.
- Monitor purchase orders, invoices, contract commitments, milestone payments, and activities impacting accrual calculations.
- Perform regular budget reviews and variance analyses to identify key drivers of financial performance.
- Reconcile differences between Finance reports and operational budget tracking systems.
- Develop spending trend analyses and provide proactive identification of financial risks and opportunities.
- Ensure budget assumptions are updated as needed based on actual spend analysis from ongoing programs.
- Serve as a primary financial business partner for Clinical Operations and Finance.
- Collaborate closely with Finance to support forecasting cycles accrual reviews, and budget submissions.
- Facilitate budget planning meetings to align assumptions and timelines.
- Gather budget inputs from OPLs and consolidate information into comprehensive forecast packages.
- Provide early visibility of significant expenditures, budget risks, and high-value commitments to OPL contacts.
- Support OPL decision making through financial insights and scenario modeling. Vendor & Contract Financial Oversight
- Partner with Vendor Management, Legal, Procurement, and Clinical Operations to ensure alignment between study budgets, contract obligations, and planned expenditures.
- Monitor vendor financial performance against approved budgets.
- Track contract milestones and anticipated expenditures across current and future fiscal years.
- Identify financial risks associated with scope changes, enrollment fluctuations, and contract amendments.
- Support budget negotiations and financial evaluations of vendor proposals when required. Reporting & Business Analytics
- Generate monthly, quarterly, and annual budget reports for OPLs.
- Create dashboards and visualizations (as needed) to communicate portfolio financial performance and forecast accuracy.
- Analyze historical spending patterns to improve future planning assumptions.
- Establish and monitor key performance indicators related to budget predictability, forecast accuracy, and spend efficiency.
- Works closely with the Clinical Operations OPLs, Clinical operations management, Finance and collaborates with Procurement, Finance, Legal, and external CRO/vendor partners.
- Bachelor's degree in Finance, Accounting, Business Administration, Life Sciences, Clinical Research, or related field.
- 5+ years of experience in clinical development finance, clinical operations finance, forecasting, FP&A, strategic planning, or related functions within biotechnology, pharmaceutical, CRO, or healthcare industries.
- Experience developing and managing clinical trial budgets and forecasts.
- Strong understanding of clinical trial cost drivers.
- Experience with budget planning, forecasting, accrual management, financial reporting, and variance analysis.
- Advanced Excel modeling and data analysis skills.
- Experience with SAP, Oracle, Adaptive Planning, Anaplan, Hyperion, or comparable financial systems.
- Ability to integrate operational assumptions into financial forecasts.
- Strong analytical, problem-solving, and business partnering capabilities.
Vacancy posted 2 hours ago
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