Remote Director, Phase I Program Development

OneOncology, LLC; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

OneOncology, LLC is seeking a Director, Phase I Program Development to build and deploy the OneR playbook for community Phase I units. You will lead design, staffing, regulatory readiness, and sponsor readiness across multiple launches, working with CSO and VP Research.

The role requires extensive Phase I infrastructure expertise, strong project management, and ability to align clinical workflows with FDA, GCP, and IRB standards in diverse community settings.

Qualifications

• Bachelor’s degree in health sciences, nursing, business or related field is required.
• Minimum 8+ years of progressive oncology research operations experience.
• Hands-on Phase I unit setup, staffing, regulatory start-up, and enrollment experience.

Responsibilities

• Design the OneOncology Phase I Unit development playbook with SOPs and checklists.
• Develop site-readiness assessments and provide phased implementation roadmaps.
• Support financial pro formas with cost assumptions for Phase I units.
• Define space requirements and create unit specifications for varied footprints.
• Design staffing models and onboarding curricula for clinical roles.
• Document clinical workflows with GCP compliance for community settings.
• Ensure FDA, ICH GCP, IRB alignment and sponsor expectations.
• Coordinate site readiness communications and handoffs to operations.
• Establish partnerships with hospitals for Phase I inpatient monitoring.
• Prepare sites for sponsor feasibility and initiation visits; report KPIs.
• Manage Phase I development tracking and quarterly progress reporting.
• Lead a Phase I Site Development working group across the network.
• Act as SME and respond to inquiries on feasibility and industry standards.

Skills

Project management

Stakeholder engagement

Written communication

Education

Bachelor's degree in health sciences, nursing, business or related field

Master's degree strongly preferred

Job description

OneOncology, LLC is seeking a Director, Phase I Program Development to build and deploy the OneR playbook for community Phase I units. You will lead design, staffing, regulatory readiness, and sponsor readiness across multiple launches, working with CSO and VP Research.

The role requires extensive Phase I infrastructure expertise, strong project management, and ability to align clinical workflows with FDA, GCP, and IRB standards in diverse community settings.