[Hiring] Director, Phase I Program Development @OneOncology

Role Description

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
• Sponsor readiness

This individual will be heavily involved during the design and launch stages of a Phase I program, serving as a key on-site contact for design and initial staff training while supporting multiple launches simultaneously.

The Director reports to the VP, Research and works in close partnership with the Chief Scientific Officer, coordinating with the Sr. Director, Site Engagement & Performance and functional Directors to ensure Phase I development is fully integrated into network infrastructure.

Responsibilities

• Design the OneOncology Phase I Unit development playbook in partnership with the CSO, Phase I teams from partner practices, and OneR leaders.
• Develop and administer a structured site-readiness assessment tool, conduct on-site discovery visits, and deliver written readiness reports with prioritized gap analysis.
• Support OneOncology’s strategic finance team in developing financial pro formas for Phase I unit stand-up costs.
• Define Phase I unit space requirements and develop space programming documents for use with real estate teams, architects, and contractors.
• Design role-specific staffing models for Phase I units and build phased staffing ramp plans, hiring profiles, competency frameworks, and onboarding curricula.
• Document and standardize clinical workflows for core Phase I operations while maintaining full GCP compliance.
• Ensure all playbook components reflect current FDA regulations, ICH GCP guidelines, IRB requirements, and sponsor expectations.
• Align Phase I program development milestones with broader site performance goals and ensure seamless handoff from program stand-up to ongoing operational oversight.
• Partner with community hospital systems to establish working agreements, clinical protocols, and care coordination pathways.
• Prepare partner sites for sponsor feasibility questionnaires and qualification visits.
• Establish and maintain a Phase I site development tracking system with clear milestones, owners, and timelines.
• Convene and facilitate a Phase I Site Development working group across the OneOncology network.
• Serve as the enterprise subject matter expert and internal consultant on Phase I program design.
• Perform additional responsibilities as needed to advance OneR’s mission.

Qualifications

• Bachelor’s degree in a health sciences, nursing, business or related field required; Master’s degree strongly preferred.
• Minimum of 8+ years of progressive oncology research operations experience with at least 3-5 years in Phase I clinical trial program.
• Direct, hands-on experience in standing up or significantly expanding a Phase I unit.
• Demonstrated experience supporting financial pro formas and building staffing models.
• Working knowledge of space planning and facility requirements for Phase I operations.
• Thorough understanding of FDA regulations, ICH GCP, IRB processes, IND requirements, and sponsor operational expectations.
• Proven project management capability managing multiple complex site engagements concurrently.
• Strong written communication skills for producing documents that others depend on.

Essential Competencies

• Deep understanding of clinical research operations within community oncology practice settings.
• Demonstrated ambition to grow and scale site-based clinical research programs.
• Energized by creating structure; comfortable moving from concept to working tool in ambiguous environments.
• Ability to influence without authority and earn confidence through expertise and credibility.
• Brings disciplined process, documentation, and follow-through habits.
• Understands how Phase I trials run day-to-day and can engage credibly with coordinators, nurses, and investigators.
• Strong working knowledge of site-level regulatory, financial, and operational requirements.
• Ability to build trust and effective partnerships with physicians and site staff.
• Proven experience improving site performance, enrollment, and operational efficiency.
• Motivated by expanding patient access to early-phase research in community settings.

This job description does not contain a full listing of activities, duties or responsibilities required of this role. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.