Director, Clinical Operations Program Lead

Pathos does not operate like a traditional biotech. There is no middle management.

There are no layers of approval. Every function, Clinical, Legal, Finance, Regulatory,

Engineering, Research, is built the same way: small teams of 3-5 subject matter experts,

each commanding 30-50 AI agents to do the work that used to require dozens of people.

• Own the clinical operational strategy for one or more oncology programs, translating asset and development strategy into actionable, phase-appropriate operational plans. 
• Serve as the single point of accountability for operational delivery, on time, on budget, and to quality, across assigned studies. 
• Orchestrate AI agents to assess program-level risk, model timeline and enrollment scenarios, and surface the trade-offs you need to make the call. 
• Own external study budgets and forecasts, from vendor spend through program-level financial planning.

• Run studies end to end (startup, site activation, enrollment, conduct, monitoring oversight, and close-out through database lock) with AI agents doing the operational heavy lifting. 
• Deploy agentic systems for continuous trial oversight: tracking site and vendor performance, detecting emerging risks and data trends, and escalating issues before they become problems. • Select, contract, and manage CROs and specialty vendors, holding them accountable to scope, timelines, quality, and budget, with agents monitoring deliverables in real time. 
• Direct AI agents to draft, assemble, and maintain operational documentation, trial master files, plans, and reports, keeping everything inspection-ready.

• Ensure all trial activity, human and agent-executed alike, meets ICH/GCP standards, applicable regulations, and Pathos SOPs. 
• Contribute clinical operations content to regulatory filings and health-authority interactions. 
• Partner across Clinical Development, Regulatory, Data Management, Biometrics, and Research to keep the program aligned and unblocked. 
• Set the operational bar and standards that both your team and your AI agents execute against as the function scales.

• Bachelor's degree in a scientific, nursing, or related field (advanced degree a plus). 
• 10+ years of clinical operations experience in biotech, pharma, or CRO settings, including demonstrated program-level strategic leadership. 
• Proven track record leading clinical trials end to end across Phase 1 to 3, from startup through database lock. 
• Deep, hands-on clinical trial management experience: CRO and vendor selection and oversight, timelines, budgets, enrollment, and monitoring strategy. 
• Direct experience in oncology drug development. 
• Experience owning and managing large external study budgets. 
• Strong command of ICH/GCP and applicable global regulatory requirements. 
• Experience in a small or emerging biotech as well as a larger pharma or CRO environment, with the versatility to operate strategically and tactically in each.

• Experience taking an oncology asset through pivotal or late-stage trials. 
• Track record building or scaling clinical operations infrastructure (SOPs, vendor frameworks, or operating models) from an early stage. 
• A technology-forward operator: you have used AI, ML, or automation to run or accelerate clinical operations, and you are energized by orchestrating agentic systems rather than growing headcount.

• Clinical trials that start, enroll, and read out on time, on budget, and to quality, with AI agents absorbing the operational load and no surprises gating the program. 
• Well-run CROs and vendors delivering to a clear, accountable standard under continuous, agent-driven oversight. 
• Inspection-ready programs and clean, defensible clinical operations content in regulatory submissions.

This is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.