Director, Clinical Operations Program Lead
- Compensation
- Not disclosed
- Location
- New York, NY
- Work setup
- Hybrid
- Seniority
- Lead
- Employment
- Contract
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.
Nice to have
- 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.
Full 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.