Phase I Trial Program Architect

Astera Cancer Care; Northern (KY); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

401(k)

Job summary

OneOncology seeks a Director of Phase I Program Development to build and deploy a scalable Phase I playbook for community practices. You will lead design, staffing, regulatory readiness, and site engagement across multiple launches, aligning with FDA/ICH/GCP standards and sponsor expectations.

You will partner with CSO, VP Research, and hospital systems to drive implementation, financial planning, and performance metrics in a fast-paced, growth-oriented environment.

Qualifications

• 8+ years in oncology research operations with Phase I focus.
• Experience standing up or expanding Phase I units from scratch.
• Strong writing and presentation skills for playbooks and reports.

Responsibilities

• Design Phase I playbook and site readiness framework.
• Develop staffing models and onboarding curricula for Phase I roles.
• Coordinate regulatory start-up and onboarding across sites.
• Ensure FDA/ICH/GCP alignment and sponsor expectations.

Skills

Phase I ops

Program management

Regulatory compliance

Cross-functional leadership

Site readiness

Education

Bachelor's in health sciences or related

Master's degree preferred

Tools

CTMS

Job description

OneOncology seeks a Director of Phase I Program Development to build and deploy a scalable Phase I playbook for community practices. You will lead design, staffing, regulatory readiness, and site engagement across multiple launches, aligning with FDA/ICH/GCP standards and sponsor expectations.

You will partner with CSO, VP Research, and hospital systems to drive implementation, financial planning, and performance metrics in a fast-paced, growth-oriented environment.