Director, Phase I Trial Unit Launch

Astera Cancer Care; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

OneOncology is seeking a Director, Phase I Program Development to build and deploy the OneR playbook for community practices to design, launch, and operate Phase I units. You will codify best practices into scalable tools, SOPs, and implementation roadmaps, working across CSO and partner sites.

Responsibilities include site readiness, financial modeling, space programming, staffing, and regulatory alignment, ensuring FDA/ICH/GCP compliance and sponsor expectations in a dynamic, multi-site

Qualifications

• Bachelor’s degree in health sciences, nursing, business or related field required.
• Master’s degree strongly preferred.

Responsibilities

• Design the Phase I Unit development playbook in partnership with CSO and partner practices.
• Develop site-readiness assessments and on-site discovery visits with leadership and champions.
• Support strategic finance in developing pro formas and cost projections.
• Define Phase I unit space requirements and create MVP and full-build specifications.
• Design staffing models for Phase I units and plan onboarding curricula.
• Document and standardize clinical workflows for Phase I operations with GCP compliance.
• Align milestones with site performance goals and ensure handoff to operations.
• Partner with hospital systems to establish working agreements and care pathways.
• Prepare sites for sponsor feasibility and initiation visits; include Phase I sites in portfolio discussions.
• Establish a Phase I site development tracking system with milestones and KPIs.
• Lead cross-network Phase I Site Development forum for knowledge sharing.

Skills

Oncology research operations

Phase I trial management

Project management

Influence without authority

Regulatory knowledge

Education

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

Master’s degree preferred

Tools

GCP compliance

IND processes

Job description

OneOncology is seeking a Director, Phase I Program Development to build and deploy the OneR playbook for community practices to design, launch, and operate Phase I units. You will codify best practices into scalable tools, SOPs, and implementation roadmaps, working across CSO and partner sites.

Responsibilities include site readiness, financial modeling, space programming, staffing, and regulatory alignment, ensuring FDA/ICH/GCP compliance and sponsor expectations in a dynamic, multi-site