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Doron Therapeutics · 1 day ago

Director of Clinical Operations (fractional) - Hybrid in Chapel Hill, NC

Chapel Hill, NC

Full-time

Hybrid

Director/Executive

10+ years exp

Doron Therapeutics is a clinical-stage biotechnology company focused on developing innovative biologic therapies for osteoarthritis. The Director of Clinical Operations will provide strategic and hands-on leadership for the planning, execution, and oversight of clinical trials, ensuring high-quality execution through effective collaboration and management of CROs and external vendors.

Biotechnology

Responsibilities

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

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

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

Develop and manage clinical operations budgets, forecasts, and vendor invoices

Optimize resource utilization while maintaining trial quality and patient safety

Qualification

Clinical operations experienceCRO managementFDA regulations knowledgeLate-stage clinical trialsBudget managementOperational planningProblem-solving attitudeCross-functional collaborationStrategic thinking

Required

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 (Phase 2/3) 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