The position will have three primary areas of responsibility:
- Clinical financial ownership (40%) — Clinical trial budgets, forecasting, expense tracking, CRO/vendor financial management, and clinical program financial modeling.
- Financial accounting and controls (40%) — Clinical accruals, monthly close support, invoicing and reconciliations, and financial reporting accuracy.
- Strategic FP&A and business partnership (20%) — Long-range planning, scenario modeling, executive reporting, and financial support for clinical operations decisions.
The position will report to the CFO while maintaining a strong dotted-line partnership with the Director of Clinical Operations.
(1) Clinical Financial Ownership:
- Lead financial planning, budgeting and forecasting for all clinical trials
- Develop and maintain detailed financial models for each clinical study, including patient enrollment, site activation, monitoring, T&E and study completion costs
- Prepare monthly, quarterly and annual clinical expense forecasts, actuals to budget reporting and analytics identifying key variances.
- Identify opportunities for cost optimization and partner with Clinical Operations to evaluate study timelines and their financial impacts of enrollment acceleration, delays or protocol changes.
- Develop key performance indicators (KPI’s) to monitor clinical trial financial performance.
- Provide financial insights to support resource allocation, trial prioritization, and trial funding decisions.
(2) Financial Accounting and Ownership:
- Manage clinical trial accounting across multiple studies and trials that tracks and analyzes expenses with clinical research organizations (CROs), clinical sites, investigators and all third-party vendors
- Ensure accurate monthly clinical expense accruals and financial reporting in accordance with U.S. GAAP
- Review clinical vendor invoices, purchase orders, and contractual payment schedules.
- Manage, monitor and issue all invoicing with site start up, patient fees and invoiceable with all related accrual accounting. Reconcile clinical trial expenditures against vendor contracts, milestones, and approved budgets.
- Monitor patient enrollment costs, procedure costs, site payments and clinical milestones.
(3) Strategic FP&A and business partnership
- Support Long-range planning, scenario modeling, any ad-hoc management reporting
- Develop standardized clinical trial budgeting and cost-tracking processes
- Develop and enhance clinical financial reporting processes, tools and dashboards
Job Qualifications:
- Bachelor’s degree in finance or accounting or related field
- 10+ years of progressive experience in financial planning, financial analysis
- 10+ years of experience supporting accounting, month end close, accruals, invoice and expense tracking
- Strong understanding of clinical trial operations, CRO contracts, clinical site payments and vendor cost structures
- Demonstrated experience managing complex clinical trial budgets and financial forecasts
- 10+ years of experience supporting clinical operations within the medical device, biotechnology industry or pharmaceutical industry
- Experience with U.S. GAAP, expense accruals and financial reporting
- Advanced Microsoft Excel skills, including complex financial modeling, scenario analysis and forecasting
- Experience with NetSuite is preferred
- Strong analytical and financial modeling capabilities
- Ability to translate clinical operational data into actionable financial insights
- Excellent communication and presentation skills
- Ability to work independently and with senior leadership without direct authority
- Strong attention to detail
- Strong business partnership and cross-functional collaboration skills