Vice President, Head of Clinical Operations
Recursion
2 days ago
Remote friendly (Salt Lake City, UT)
United States
Clinical Research and Development
Vice President, Head of Clinical Operations
In this role, you will:
- Lead clinical operations strategy and execution across the full clinical portfolio (IND/CTA planning through first-in-human, proof-of-concept, pivotal trials, study closeout, and submission support)
- Own end-to-end operational delivery: study planning, feasibility, country/site strategy, start-up, enrollment, monitoring, vendor oversight, budget management, database lock readiness, and closeout
- Build, scale, and mentor a high-performing Clinical Operations organization (clinical project management, clinical trial management, outsourcing/vendor oversight, portfolio operations)
- Establish portfolio-level governance, operating rhythms, KPIs/dashboards, risk management, resource planning, and escalation pathways
- Lead CRO and vendor strategy relationships (outsourcing model, selection, contracting, performance management, issue escalation, budget forecasting)
- Ensure inspection-ready execution with GCP compliance, SOP adherence, TMF oversight, risk-based quality management, audit readiness, and CAPA management
The experience you’ll need:
- Bachelor’s degree in a scientific/healthcare/related field (advanced degree preferred)
- 15+ years clinical operations experience in biotech/pharma; leadership overseeing multiple global clinical programs
- Track record across early development to pivotal/registration-enabling studies, closeout, and submission support
- Deep knowledge of clinical trial planning/execution (feasibility, start-up, enrollment, monitoring, CRO/vendor oversight, budgets, risk management, database lock, closeout)
- Working knowledge of FDA/EMA/MHRA, ICH-GCP, global regulations, inspection readiness, risk-based quality management
- Experience building/leading cross-functional clinical operations teams
- Executive presence and ability to influence senior stakeholders and resolve complex issues
- Preferred: oncology, rare disease, and/or specialty development; plus experience with CTMS/eTMF/EDC/IRT/eCOA, dashboards, automation, or AI-enabled workflows
Working location & compensation:
Hybrid in Salt Lake City, Utah (50% in office). Estimated base range: $303,600–$364,100 (USD), plus annual bonus, equity, and comprehensive benefits.
In this role, you will:
- Lead clinical operations strategy and execution across the full clinical portfolio (IND/CTA planning through first-in-human, proof-of-concept, pivotal trials, study closeout, and submission support)
- Own end-to-end operational delivery: study planning, feasibility, country/site strategy, start-up, enrollment, monitoring, vendor oversight, budget management, database lock readiness, and closeout
- Build, scale, and mentor a high-performing Clinical Operations organization (clinical project management, clinical trial management, outsourcing/vendor oversight, portfolio operations)
- Establish portfolio-level governance, operating rhythms, KPIs/dashboards, risk management, resource planning, and escalation pathways
- Lead CRO and vendor strategy relationships (outsourcing model, selection, contracting, performance management, issue escalation, budget forecasting)
- Ensure inspection-ready execution with GCP compliance, SOP adherence, TMF oversight, risk-based quality management, audit readiness, and CAPA management
The experience you’ll need:
- Bachelor’s degree in a scientific/healthcare/related field (advanced degree preferred)
- 15+ years clinical operations experience in biotech/pharma; leadership overseeing multiple global clinical programs
- Track record across early development to pivotal/registration-enabling studies, closeout, and submission support
- Deep knowledge of clinical trial planning/execution (feasibility, start-up, enrollment, monitoring, CRO/vendor oversight, budgets, risk management, database lock, closeout)
- Working knowledge of FDA/EMA/MHRA, ICH-GCP, global regulations, inspection readiness, risk-based quality management
- Experience building/leading cross-functional clinical operations teams
- Executive presence and ability to influence senior stakeholders and resolve complex issues
- Preferred: oncology, rare disease, and/or specialty development; plus experience with CTMS/eTMF/EDC/IRT/eCOA, dashboards, automation, or AI-enabled workflows
Working location & compensation:
Hybrid in Salt Lake City, Utah (50% in office). Estimated base range: $303,600–$364,100 (USD), plus annual bonus, equity, and comprehensive benefits.