Director, Clinical Business Operations
Nuvation Bio
17 days ago
Remote friendly (United States)
United States
Operations
Responsibilities
- Lead development, management, and oversight of clinical trial budgets across phases (I–IV).
- Partner with Clinical Operations to build study-level and program-level forecasts; monitor actual spend vs. budget and report variances.
- Establish clinical finance tracking tools/dashboards; support long-range planning, portfolio modeling, and scenario analyses.
- Oversee end-to-end clinical contract lifecycle (MSAs, work orders, change orders, site agreements); lead negotiations with CROs/vendors/sites.
- Ensure financial assumptions align with contractual obligations; streamline templates/processes with Legal and Procurement.
- Manage contract amendments and ensure documentation/audit readiness.
- Serve as key business partner to Clinical Operations, Finance, Legal, and Procurement; provide financial guidance during planning/execution.
- Support governance meetings (budget reviews/investment decisions) and align clinical financial strategy to corporate goals.
- Develop scalable processes/SOPs/best practices; optimize systems (CTMS, ERP, contract lifecycle tools); drive automation/standardization.
- Ensure compliance with internal policies/financial controls/regulatory requirements; support audits; identify and mitigate financial/contractual risks.
- Build, lead, and mentor a clinical finance/contracts team; foster accountability and continuous improvement; provide training.
Qualifications
- Bachelor’s degree; 10+ years in clinical finance, clinical outsourcing, or contract management (biotech/pharma).
- 5+ years leadership/people management.
- Strong understanding of clinical trial processes and cost drivers across phases (I–IV).
Skills & Technical Proficiency
- Deep expertise in budgeting, forecasting, and financial modeling; advanced Excel.
- Proven ability to negotiate complex clinical contracts.
- Knowledge of industry benchmarks/cost structures; strong analytical/problem-solving skills.
- Strong stakeholder management and communication.
- Experience with SAP/Oracle/NetSuite; familiarity with CTMS and EDC platforms.
Preferred
- Small-to-mid biotech or fast-growing environment; global trial experience; experience implementing/optimizing clinical finance/contract systems.
- Lead development, management, and oversight of clinical trial budgets across phases (I–IV).
- Partner with Clinical Operations to build study-level and program-level forecasts; monitor actual spend vs. budget and report variances.
- Establish clinical finance tracking tools/dashboards; support long-range planning, portfolio modeling, and scenario analyses.
- Oversee end-to-end clinical contract lifecycle (MSAs, work orders, change orders, site agreements); lead negotiations with CROs/vendors/sites.
- Ensure financial assumptions align with contractual obligations; streamline templates/processes with Legal and Procurement.
- Manage contract amendments and ensure documentation/audit readiness.
- Serve as key business partner to Clinical Operations, Finance, Legal, and Procurement; provide financial guidance during planning/execution.
- Support governance meetings (budget reviews/investment decisions) and align clinical financial strategy to corporate goals.
- Develop scalable processes/SOPs/best practices; optimize systems (CTMS, ERP, contract lifecycle tools); drive automation/standardization.
- Ensure compliance with internal policies/financial controls/regulatory requirements; support audits; identify and mitigate financial/contractual risks.
- Build, lead, and mentor a clinical finance/contracts team; foster accountability and continuous improvement; provide training.
Qualifications
- Bachelor’s degree; 10+ years in clinical finance, clinical outsourcing, or contract management (biotech/pharma).
- 5+ years leadership/people management.
- Strong understanding of clinical trial processes and cost drivers across phases (I–IV).
Skills & Technical Proficiency
- Deep expertise in budgeting, forecasting, and financial modeling; advanced Excel.
- Proven ability to negotiate complex clinical contracts.
- Knowledge of industry benchmarks/cost structures; strong analytical/problem-solving skills.
- Strong stakeholder management and communication.
- Experience with SAP/Oracle/NetSuite; familiarity with CTMS and EDC platforms.
Preferred
- Small-to-mid biotech or fast-growing environment; global trial experience; experience implementing/optimizing clinical finance/contract systems.