Director, Phase I Program Development

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 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 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, coordinate site readiness communications, and ensure seamless handoff from program stand-up to ongoing operational oversight.* Partner with community hospital systems and inpatient facility leadership to establish the working agreements, clinical protocols, and care coordination pathways required to support Phase I inpatient monitoring stays.* Prepare partner sites for sponsor feasibility questionnaires, qualification visits, and site initiation visits; partner with the CSO and Program Management to include emerging Phase I sites in network-level sponsor conversations and portfolio growth strategies.* Establish and maintain a Phase I site development tracking system with clear milestones, owners, and timelines; report progress quarterly to the CSO and executive leadership against defined KPIs including time-to-activation, enrollment ramp, and first-year financial performance versus pro forma.* Convene and facilitate a Phase I Site Development working group across the OneOncology network creating a structured forum for peer learning, issue escalation, playbook iteration, and shared problem-solving among practices in various stages of program development.* Serve as the enterprise subject matter expert and internal consultant on Phase I program design; respond to ad hoc inquiries from site leadership, the CSO, and executive stakeholders regarding feasibility, best practices, and emerging industry standards in early-phase community research.* Perform additional responsibilities as needed to advance OneR’s mission of improving the lives of everyone living with cancer.**Required or Preferred 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 working directly in Phase I clinical trial program.* Direct, hands-on experience in standing up or significantly expanding a Phase I unit — including facility preparation, team hiring and training, regulatory start-up, and first-patient enrollment. Candidates who have done this work from scratch are strongly preferred.* Demonstrated experience supporting financial pro formas and building staffing models, and operational business cases for clinical research programs.* Working knowledge of space planning and facility requirements for Phase I operations, including GCP and FDA-relevant standards for clinical research facilities.* Thorough understanding of FDA regulations, ICH GCP, IRB processes, IND requirements, and sponsor operational expectations for Phase I trial conduct.* Proven project management capability demonstrating ability to manage multiple complex site engagements concurrently, across diverse stakeholders, with limited direct authority.* Strong written communication skills as this role produces documents (playbooks, pro formas, SOPs, assessment reports) that others depend on; writing quality matters.**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. Earns the confidence of physician champions, practice administrators, and executive stakeholders through expertise and credibility, not positional authority.* Brings disciplined process, documentation, and follow-through habits to a role where those habits create infrastructure others depend on.* Understands how Phase I trials actually run day-to-day and can engage credibly with coordinators, nurses, and investigators on workflow details.* 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.