Director, Clinical Operations Program Lead

About the role

Pathos is an AI and technology company that develops drugs via its Foundry platform, which decides which assets to invest in, trial designs to pivot, and programs to stop. Founded on a foundation model trained on 200+ petabytes of multimodal data (DNA, RNA, pathology, clinical text), the platform’s three engines—Scout, Foundry, and Sprint—enable a “biotech in a box” approach. The company is well‑capitalized, runs three clinical‑stage oncology programs, and has a co‑development partnership with a top‑five pharma. Leadership brings nearly two decades of company‑building experience and multiple successful exits. Pathos operates without middle management; small teams of 3‑5 subject‑matter experts each command 30‑50 AI agents to perform work that once required dozens of people, measuring product velocity in hours. The Director, Clinical Operations Program Lead will own operational strategy and end‑to‑end execution of clinical programs, acting as the operator who sets clinical operational direction and commands a fleet of AI agents to carry it out from study startup through database lock.

Responsibilities

• 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 trade‑offs for decision‑making; 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.

Requirements

• 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.

Qualifications

• 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.

Pay

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