Executive Director, Clinical Operations

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $285k - $310k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Spyre Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Spyre Therapeutics is a biopharmaceutical company focused on developing therapies for Inflammatory Bowel Disease (IBD). The company is committed to creating best-in-class antibodies, rational therapeutic combinations, and employing precision immunology approaches to enhance treatment efficacy and convenience for IBD patients. With a team experienced in developing and commercializing treatments across various diseases, Spyre Therapeutics is dedicated to improving treatment options and outcomes for patients through advanced research in immunology. The company fosters a collaborative and innovative environment to achieve its mission of providing promising new treatment options for IBD.

📋 Description

• 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

• 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

• 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