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Executive Director, Clinical Operations
Spyre Therapeutics. Provide strategic leadership and hands-on oversight of global clinical trials within timelines, budgets, quality standards, and regulatory requirements .
About the role
Key responsibilities & impact- Provide strategic leadership and hands-on oversight of global clinical trials within timelines, budgets, quality standards, and regulatory requirements
- Translate clinical development objectives into operational plans and lead trial execution from start-up through closeout
- Lead development and execution of clinical operational strategies and study plans
- Oversee feasibility, start-up, enrollment, trial conduct, database lock, and closeout activities
- Establish and manage timelines, budgets, resource plans, and performance metrics
- Identify risks, establish mitigation plans, and drive issue resolution
- Partner with Clinical Development and cross-functional teams on protocol feasibility and trial documents
- Lead CRO and vendor selection, contracting, governance, and performance oversight
- Build relationships with investigators and site teams to support recruitment, retention, and issue resolution
- Develop and oversee enrollment strategies and address recruitment challenges
- Partner with Data Management, Biometrics, Clinical Development, and other functions to support data quality, query resolution, database lock, and reporting
- Manage study budgets, contract and budget negotiations, forecasts, invoices, and payments with Finance and Legal
- Partner with Quality on inspection readiness, audits, regulatory inspections, findings, and corrective actions
- Develop and maintain Clinical Operations SOPs, processes, and tools; provide training and drive improvements
- Provide updates to senior leadership and Development Teams on progress, budget performance, risks, and escalations
- Lead, mentor, and develop Clinical Operations personnel
- Maintain knowledge of therapeutic areas, clinical trial practices, guidelines, and regulations
- Present to senior staff and participate in Development Team meetings
- Attend scientific and external training meetings as needed
- Perform other clinical operations activities as required
Requirements
What you’ll need- Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred
- Minimum of 10 years of global clinical research experience within the pharmaceutical or biotechnology industry
- Late-stage dermatology clinical trial experience strongly preferred
- Demonstrated success overseeing clinical trial planning, start-up, enrollment, monitoring, data cleaning, database lock, closeout, and clinical trial reporting
- Experience leading CROs and other clinical service providers, including vendor selection, contract negotiation, governance, and performance management
- Strong financial and operational management skills, including study budgeting, forecasting, resource planning, and risk management
- Thorough understanding of Good Clinical Practice and applicable local and global clinical trial requirements
- Experience supporting audits, regulatory inspections, and inspection readiness
- Experience contributing to protocols, SOPs, clinical study reports, and regulatory submissions preferred
- Ability to lead and develop Clinical Operations personnel and guide cross-functional teams through influence
- Excellent communication, interpersonal, and decision-making skills
- Ability to communicate complex issues and recommendations clearly to senior leadership
- Ability to manage competing priorities, adapt to changing needs, and combine strategic thinking with hands-on execution
Benefits
Comp & perks- Market competitive compensation and benefits package
- Performance bonus
- Equity grant opportunities
- Health, welfare & retirement benefits
- Unlimited PTO
- Two, one-week company-wide shutdowns each year
- Professional development opportunities
- Remote working environment with frequent in-person meetings
- Opportunity to work in a fast-paced, dynamic environment, help shape company culture, contribute to meaningful medicines, and learn quickly