Director, Clinical Operations Program Lead

Socket.dev; New York (NY); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Pathos is seeking a Director, Clinical Operations Program Lead to own the operational strategy and end-to-end execution of clinical programs. You will orchestrate AI agents to manage study startup through database lock, translating asset strategy into executable trials and transparent operations.

This foundational role reports to the Chief Clinical Operations Officer and collaborates with Regulatory, Data Management, Biometrics, and Research to balance timelines, quality, and budget, while AI

Qualifications

• Bachelor’s degree in a scientific, nursing, or related field.
• 10+ years of clinical operations experience with program-level leadership.
• Proven track record leading trials end-to-end (Phase 1–3).
• Experience managing CROs/vendors and budgets.

Responsibilities

• Define and own operational strategy for oncology programs.
• Oversee end-to-end trial execution with AI agents handling operational load.
• Ensure compliance with ICH/GCP and regulatory requirements.
• Collaborate across functions to keep programs aligned and unblocked.

Skills

Clinical operations leadership

Oncology trial execution

Program management

AI agent orchestration

Education

Bachelor's degree in science or nursing

Advanced degree preferred

Job description

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.