Director, Phase I Program Development (Oncology Clinical Research)

Location: United States; remote role

Company

hirify.global develops a patient-centric, physician-driven, and technology-powered oncology care and research network supporting independent community oncology practices.

What you will do

• Design and deploy a scalable Phase I program development playbook with frameworks, SOPs, checklists, decision tools, and implementation pathways.
• Assess partner-site readiness through discovery visits, gap analyses, readiness reports, and phased implementation roadmaps.
• Define Phase I unit space requirements, staffing models, hiring profiles, competency frameworks, onboarding curricula, and financial planning assumptions.
• Standardize GCP-compliant workflows for screening, enrollment, investigational product management, dose escalation, safety monitoring, adverse-event reporting, specimen handling, and sponsor communication.
• Prepare sites for sponsor feasibility, qualification, and initiation activities while coordinating with hospital systems on inpatient monitoring pathways.
• Track launch milestones and KPIs, facilitate the network-wide site development working group, and serve as the enterprise subject matter expert for Phase I program design.

Requirements

• Bachelor’s degree in health sciences, nursing, business, or a related field; a master’s degree is strongly preferred.
• 8+ years of progressive oncology research operations experience, including 3–5 years working directly with Phase I clinical trials.
• Hands-on experience standing up or significantly expanding a Phase I unit, including facility preparation, team hiring and training, regulatory start-up, and first-patient enrollment.
• Experience developing financial pro formas, staffing models, and operational business cases for clinical research programs.
• Strong knowledge of FDA regulations, ICH GCP, IRB processes, IND requirements, sponsor expectations, and Phase I facility standards.
• Proven ability to manage multiple complex site engagements, influence stakeholders without direct authority, and produce high-quality operational documentation.

Culture & Benefits

• Remote work in the United States.
• Values-driven culture combining startup enthusiasm with support from leaders in oncology, urology, technology, and finance.
• Opportunity to expand patient access to early-phase research in community settings.
• Collaboration with physician champions, practice administrators, hospital leaders, research teams, and executive stakeholders.