Executive Director, Clinical Operations
S
Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeDirector
Salary285,000 - 310,000 USD per year
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Job Details
- Experience
- A minimum of 10 years of global clinical research experience within the pharmaceutical or biotechnology industry.
- Required Skills
- Risk Management
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline required.
- Advanced degree preferred.
- At least 10 years of global clinical research experience within the pharmaceutical or biotechnology industry.
- Late-stage dermatology clinical trial experience strongly preferred.
- Demonstrated success overseeing trial planning, start-up, enrollment, monitoring, data cleaning, database lock, closeout, and clinical trial reporting.
- Experience leading CROs and clinical service providers, including vendor selection, contract negotiation, governance, and performance management.
- Strong study budgeting, forecasting, resource planning, operational management, and risk management skills.
- 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.
Responsibilities
- Lead clinical operational strategies and study plans aligned with clinical development priorities and corporate objectives.
- Oversee global clinical trials from feasibility and start-up through enrollment, trial conduct, database lock, and closeout.
- Manage trial timelines, budgets, resource plans, and performance metrics; identify risks and drive mitigation.
- Partner with Clinical Development and cross-functional colleagues on protocol feasibility and trial-related documents.
- Lead CRO and vendor selection, contracting, governance, and performance oversight.
- Oversee country and site feasibility, selection, activation, monitoring, and closeout; build relationships with investigators and site teams.
- Develop enrollment strategies with Medical Affairs and address recruitment challenges.
- Partner with Data Management, Biometrics, Clinical Development, Finance, Legal, and Quality on data quality, budgets, inspection readiness, and reporting.
- Develop Clinical Operations SOPs, processes, and tools, and provide training.
- Provide study updates to senior leadership and Development Teams; lead, mentor, and develop Clinical Operations personnel.
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