Director, Clinical Operations Program Lead

PATHOS; New York (NY); Hybrid; USD 180,000 - 200,000; Full time

Job summary

Pathos is an AI-driven biotech company redefining drug development with Foundry guiding portfolio choices. A Director, Clinical Operations Program Lead will own operational strategy and end-to-end execution of clinical programs, coordinating with Clinical Development, Regulatory, and Data Management to keep trials on time and in scope.

The role requires a strong operations background in oncology, extensive external vendor oversight, and a technology-forward approach using AI agents to drive

Qualifications

• 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; program-level leadership.
• Proven track record leading trials end-to-end (Phase 1–3).
• Experience in oncology drug development and external vendor management.
• Strong knowledge of ICH/GCP and global regulations.
• Versatility across small biotech and large pharma/CRO environments.

Responsibilities

• Own the operational strategy for oncology programs and translate asset strategy into actionable plans.
• Serve as the accountability point for delivery on time, on budget, and on quality.
• Orchestrate AI agents to assess risk, timelines, and enrollment scenarios.
• Manage external study budgets and forecasts from vendor spend to financial planning.
• Run end-to-end trials with AI agents handling operational load.
• Draft and maintain trial documentation and master files for inspections.
• Partner with Clinical Development and Regulatory to keep programs aligned.

Skills

Clinical operations

Program leadership

Budget management

Vendor management

ICH/GCP knowledge

Oncology drug development

Education

Bachelor's degree in a scientific field

Advanced degree (MS/PhD) preferred

Tools

AI agents

Automation

Job description

Director, Clinical Operations Program Lead

Drug development shouldn’t be guesswork, not when patients are waiting.

Pathos is an AI and technology company that develops drugs. Foundry, our platform,

decides which ones.

We are not a biotech that uses AI. We are redesigning drug development from first

principles around an AI and technology core. Our Foundation Model reads across DNA,

RNA, pathology, and clinical text on 200+ petabytes of Multimodal data. Our Foundry

platform turns that model into live portfolio decisions: which asset to invest in, which trial

design to pivot, which program to stop. In 2026, every major portfolio decision

at Pathos was Foundry-informed, a Platform-Informed Decisions score of 4 out of 4.

The three engines of the platform are Scout (finds assets other companies would miss),

Foundry (decides where capital and clinical attention go), and Sprint (executes trials with

AI agents doing the work that used to require a full biotech). We call it a biotech

company in a box.

We are well-capitalized. We have three clinical-stage oncology programs, and a co-development partnership with a top-five pharma. Our leadership has

nearly two decades of company-building experience and multiple successful exits behind

them.

How We Build

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.

Everyone builds. Everyone ships. Product velocity is measured in hours, not weeks. A team of 40-50 operators does the work of a traditional biotech of 300. Every dollar saved

on overhead is a dollar deployed into a clinical program.

The people who thrive here are operators: deep experts who can specify what needs to

happen, orchestrate AI agents to execute at scale, and make high-judgment calls that

compound over time. If you have spent your career building and shipping in your

domain, this is the environment where that experience becomes a superpower.

About the Role

We are seeking a Director, Clinical Operations Program Lead to own the operational strategy and end-to-end execution of our clinical programs. At Pathos, that does not mean building and running a large operations team. It means 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. You will translate asset strategy into executable trials, then orchestrate agentic systems to run the day-to-day: tracking timelines and enrollment, monitoring site and vendor performance, surfacing risks, and drafting the operational documentation that used to take a full team.

This is a foundational hire on the Pathos Clinical Operations team, reporting to the Chief Clinical Operations Officer and partnering closely with Clinical Development, Regulatory, Data Management, Biometrics, and Research. You are equally comfortable setting program-level strategy and getting into the detail of a single study. You know how to get a trial from concept to first-patient-in and through close-out, how to hold CROs and vendors accountable, and how to make the high-judgment calls that keep timelines, quality, and budget in balance, with AI agents handling the operational load so your time goes to the decisions that matter.

What You Will Do

Program Strategy & Operational Leadership

• 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.

Agent-Driven Trial Execution

• 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.

Quality, Compliance & Cross-Functional Partnership

• 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.

Who You Are

Required Qualifications

• 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.

Preferred 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.

What Success Looks Like

• 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.

Location

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

The pay range for this role is:

180,000 - 200,000 USD per year (New York Office - ACLS East Tower)