Overview
Looking to be part of something more meaningful? At HonorHealth, you'll be part of a team, creating a multi-dimensional care experience for our patients. You'll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let's go beyond expectations and transform healthcare together. HonorHealth is one of Arizona's largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 17,000 team members, 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com.
Responsibilities
Job SummaryReporting to the Chief Operating Officer of the HonorHealth Research Institute (HRI), the Director of the Research Sponsor Management Office (SMO) serves as the institution's senior leader responsible for fulfilling all Sponsor obligations associated with clinical research conducted under the HonorHealth Sponsor umbrella. The Director provides comprehensive oversight of the full lifecycle of Investigator-Initiated Trials (IITs)-from concept development to study closeout and publication-and ensures that every regulatory, scientific, operational, and quality requirement is met with precision and integrity. This role establishes a centralized office that functions as the operational and regulatory backbone for HonorHealth's responsibilities as a Sponsor, ensuring compliance with FDA regulations, ICH-GCP standards, and institutional policies. The Director leads a multidisciplinary team, collaborates closely with investigators and clinical departments, and oversees all documentation, processes, and communications necessary to launch, manage, and close IITs at both single-site and multicenter levels. Through strategic leadership and rigorous operational management, this role supports HRI's mission to advance innovative research that improves patient outcomes and elevates HonorHealth as a leader in clinical investigation.
Essential FunctionsScientific & Protocol Development Oversight:
- Leads all Sponsor-required activities in the development phase of IITs, ensuring every study begins with a sound scientific foundation. This includes guiding investigators through the creation of complete and compliant protocols, informed consent forms, investigator brochures, and regulatory dossiers. The Director ensures that study documents accurately capture endpoints, safety requirements, visit schedules, and operational workflows. They also direct the development of case report forms, statistical considerations, study manuals, and all documents necessary for FDA submissions or IND/IDE support.
Regulatory, Compliance & Sponsor Governance:
- Acting as the institutional expert on Sponsor obligations, the Director ensures that HonorHealth fully meets all FDA, ICH-GCP, and institutional requirements throughout the study lifecycle. This includes overseeing preparation and maintenance of IND/IDE filings, safety reporting, annual updates, essential document management, and timely reporting to regulatory bodies. The Director builds and maintains a Sponsor Quality Management System, formalizes procedures and SOPs, and establishes governance structures that ensure study integrity, subject safety, documentation accuracy, and inspection readiness.
Operational Leadership Across Trial Activation & Conduct:
- Provides comprehensive operational oversight once a study transitions from development into active conduct. This includes management of monitoring plans, communication pathways, site oversight, risk mitigation activities, vendor relationships, and safety management systems. They ensure consistent implementation of study procedures, maintain Sponsor-site communication, track study performance, and intervene to correct issues that impact compliance, quality, or timelines. By coordinating internal teams and external partners, the Director keeps studies moving forward with clarity, efficiency, and scientific rigor.
Multicenter Trial Oversight, Coordination & Performance Management:
- For multicenter IITs, the Director functions as the central coordinating authority overseeing all participating sites. Responsibilities include site feasibility, qualification, onboarding, training, and ongoing operational management. They ensure study drug management, laboratory workflows, data collection, and monitoring are standardized across sites. The Director evaluates site performance, resolves operational gaps, coordinates corrective actions, and ensures continuity of communication across investigators, coordinators, vendors, and institutional partners. Their oversight ensures multicenter studies operate cohesively and maintain consistent quality across all locations.
Study Closeout, Reporting, Dissemination & Scientific Partnership:
- Upon study completion, Oversee data lock, final monitoring, essential document reconciliation, and regulatory closeout. They ensure final IND/IDE reporting obligations are met, ClinicalTrials.gov postings are accurate and timely, and study results are disseminated responsibly. The Director partners with investigators and communications teams to support abstract preparation, manuscript development, conference submissions, and long-term data sharing requirements. Their leadership ensures that completed studies transition smoothly into publication, reporting, and archiving, preserving the scientific value and compliance integrity of each IIT.
Other Duties:
- Collaborate with other HonorHealth Sr. Leaders in the strategic planning and implementation of novel opportunities and ideas.
Education
- Bachelor's Degree in Life Sciences, Business Administration, or related field. - Required
- Advanced degree (Ph.D., or Master's) in scientific discipline. - Preferred
Experience
- 8 years in research program leadership, including 5+ years in clinical trial program oversight. - Required
- Proven track record of developing research portfolios through partnerships or extramural funding. - Required
- Experience managing complex, multi-stakeholder projects (e.g., NIH grants, industry-sponsored trials). - Required
- Experience with federal funding and clinical trial development. - Preferred
License and Certifications
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HonorHealth
Jan 13, 2026