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 the Clinical Operations organization (clinical project management, trial management, outsourcing/vendor oversight, portfolio operations)
- Establish portfolio-level governance: operating rhythms, KPIs/dashboards, risk management, resource planning, and escalation pathways
- Lead CRO/vendor strategy: outsourcing model, selection, contracting partnership, performance management, issue escalation, and budget forecasting
- Ensure inspection-ready execution via GCP compliance, SOP adherence, TMF oversight, risk-based quality management, audit readiness, and CAPA management
The Experience Youβll Need
- Bachelorβs degree in a scientific/healthcare/related field (advanced degree preferred)
- 15+ years clinical operations experience in biotech/pharma; leadership overseeing multiple global programs/trials
- Track record from early development through pivotal/registration-enabling trials, closeout, and submission support
- Deep clinical trial planning/execution experience (feasibility, start-up, enrollment, monitoring, vendor/CRO oversight, budgets, risk management, database lock, closeout)
- Working knowledge of FDA/EMA/MHRA, ICH/GCP, global regulations, inspection readiness, and risk-based quality management
- Experience building/leading teams and influencing senior stakeholders
- Preferred: oncology/rare disease/specialty development; plus CTMS/eTMF/EDC/IRT/eCOA, operational dashboards, automation, and/or AI-enabled workflows
Working Location
- Fully remote; occasional travel as needed
Compensation/Benefits
- Annual base salary range: $333,000β$400,510 (NYC/Boston/SF Bay Area) or $303,600β$364,100 (Salt Lake City & other U.S. locations); eligible for annual bonus, equity, and comprehensive benefits