Director, Phase I Clinical Program Enablement - Remote

Astera Cancer Care; Nashville (TN); On-site; USD 170,000 - 230,000; Full time

Job summary

OneOncology seeks aDirector of Phase I Program Development to build the OneR playbook, enabling partner practices to design, plan, and launch Phase I units across the network. You will codify best practices for staffing, space, workflows, regulatory readiness, and sponsor communications.

You’ll lead on-site readiness efforts, train staff, and coordinate with CSO, VP Research, and site leaders to ensure rapid, compliant activations across diverse community settings.

Qualifications

• Advanced understanding of Phase I operations in oncology.
• Experience building scalable playbooks, SOPs, and checklists for clinical programs.
• Strong grasp of FDA regulations, ICH GCP, IRB processes, IND requirements.

Responsibilities

• Design the Phase I Unit development playbook with CSO and practice leaders.
• Develop site-readiness assessments and prioritize gap analyses.
• Create staffing ramp plans and onboarding curricula for Phase I roles.
• Document core workflows: screening, enrollment, dose escalation, safety, AE reporting.
• Align milestones with network KPIs and manage cross-site communications.
• Lead Phase I site development forums for peer learning and issue resolution.

Skills

Phase I program development

Project management

Regulatory knowledge

Financial planning

Staffing models

Stakeholder management

Education

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

Master’s degree preferred

Job description

OneOncology seeks aDirector of Phase I Program Development to build the OneR playbook, enabling partner practices to design, plan, and launch Phase I units across the network. You will codify best practices for staffing, space, workflows, regulatory readiness, and sponsor communications.

You’ll lead on-site readiness efforts, train staff, and coordinate with CSO, VP Research, and site leaders to ensure rapid, compliant activations across diverse community settings.