Director of Clinical Operations

Company Description

Doron Therapeutics is a clinical-stage biotechnology company focused on developing innovative biologic therapies for osteoarthritis. Our lead program, MOTYS, is in Phase 3 clinical development with the goal of delivering meaningful, durable relief for patients suffering from chronic joint disease. Doron is headquartered in Chapel Hill, NC, and operates with a lean, highly collaborative team culture. 

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Role Description

The Director of Clinical Operations (fractional) will provide strategic and hands-on leadership for the planning, execution, and oversight of Doron Therapeutics’ clinical trials, with a primary focus on late-stage (Phase 3) development. This individual will be responsible for ensuring high-quality, on-time, and on-budget clinical trial execution through effective cross-functional collaboration and management of CROs and external vendors.    

This role requires a strong blend of operational rigor, strategic thinking, and the ability to operate effectively in a fast-paced, resource-conscious clinical-stage biotech environment.  

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Key Responsibilities

Clinical Trial Oversight 

• Lead the operational planning and execution of Doron’s Phase 3 clinical development programs 
• Develop and manage clinical operations plans, timelines, budgets, and risk mitigation strategies. 
• Ensure trials are conducted in compliance with ICH-GCP, FDA regulations, and applicable global regulatory requirements. 

​CRO and Vendor Management 

• Select, oversee, and manage CROs and clinical vendors to ensure high-quality deliverables and adherence to timelines and budgets. 
• Serve as the primary operational point of contact for CROs, fostering strong partnerships while driving accountability. 
• Review and approve CRO work plans, monitoring plans, and key operational metrics. 
• Select and monitor appropriate KPI’s to ensure timely and on budget execution.

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Site and Study Oversight 

• Oversee site identification, activation, enrollment, retention, and close-out activities. 
• Monitor study performance metrics and proactively address enrollment or operational challenges. 
• Ensure inspection of readiness and support audits and regulatory inspections. ​

Budget and Resource Management 

• Develop and manage clinical operations budgets, forecasts, and vendor invoices. 
• Optimize resource utilization while maintaining trial quality and patient safety. 

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Qualifications

• Bachelor’s degree in life sciences or a related field; advanced degree preferred. 
• 10+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments. 
• Demonstrated experience with late-stage (Phase2/ 3) clinical trials. 
• Proven experience managing CROs and external vendors. 
• Strong working knowledge of FDA and international regulatory regulations, and global clinical trial requirements. 
• Experience partnering cross-functionally with CMC, Quality, and external manufacturing organizations to support clinical supply and late-stage development. 
• Ability to operate both strategically and tactically in a lean organization. 
• Can do, hands-on, problem-solving attitude; ability to effectively and collaboratively operate in a lean environment.

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Location & Travel

• Flexible / hybrid, with preference for candidates able to work closely with the Chapel Hill, NC team. 
• Commitment to work with Australian business hours twice weekly.
• This role is a fractional role estimated to be no more than 25 hours / week, that varies based on the demands of the project.

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Why Doron Therapeutics

• Opportunity to play a pivotal role in advancing a Phase 3 program with meaningful patient impact. 
• High-visibility impactful, leadership role within a lean, highly collaborative, mission-driven team. 
• Ability to shape and scale clinical operations during a critical stage of company growth. 
• Compensation includes salary, access to monthly health care stipend, and equity participation. 

This job description is intended to describe the general nature and level of work being performed and is not an exhaustive list of all responsibilities. 

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How to Apply

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