OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.
Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of independent physicians and the patients they serve.
Job Description:
Role Summary: The Director, Phase I Program Development is responsible for building and deploying the OneR playbook that enables OneOncology partner practices to plan, design, and launch Phase I clinical trial units. This is a senior operational and program management position requiring extensive Phase I infrastructure expertise built from the ground up.
The Director will extract, codify, and package institutional best practices at community-based Phase I units into scalable frameworks that community practices including financial planning, space design, staffing, clinical workflows, regulatory infrastructure, and sponsor readiness. The individual will be heavily involved during the design and launch stages of a Phase I program, where they will serve as a key on-site contact for design and initial staff training. This individual will be supporting multiple launches simultaneously.
The Director reports to the VP, Research and works in close partnership with the Chief Scientific Officer. Internally, this role works in close coordination with the Sr. Director, Site Engagement & Performance and with functional Directors to ensure Phase I development is fully integrated into network infrastructure. It also serves as the primary interface between the network research platform and independent, highly autonomous community oncology practices with diverse needs, expectations, and operating models. This role requires exceptional judgment, resilience, and the ability to operate effectively across a wide range of practice cultures and starting points.
Responsibilities:
Design the OneOncology Phase I Unit development playbook in partnership with the CSO, Phase I teams from partner practices, and OneR leaders translating institutional expertise and industry best practices into replicable frameworks, decision tools, SOPs, checklists, and tiered implementation pathways for practices at varying stages of readiness.
Develop and administer a structured site-readiness assessment tool, conduct on-site discovery visits with practice leadership and physician champions, and deliver written readiness reports with prioritized gap analysis and phased implementation roadmaps.
Support OneOncology’s strategic finance team in their development of financial pro formas by providing detailed assumptions for Phase I unit stand-up costs including capital requirements and operational expense projections.
Define Phase I unit space requirements and develop space programming documents for use with real estate teams, architects, and contractors; create both minimum viable and full-build unit specifications to accommodate varying practice footprints and investment levels.
Design role-specific staffing models for Phase I units covering CRCs, Research Nurses, Regulatory Coordinators, and Data Managers and build phased staffing ramp plans, hiring profiles, competency frameworks, and onboarding curricula for each role.
Document and standardize clinical workflows for core Phase I operations including screening, enrollment, IP management, dose escalation, safety monitoring, AE reporting, specimen handling, and sponsor/CRO communication adapted for community practice environments while maintaining full GCP…