Director, Regulatory Operations

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Regulatory Operations Director oversees the Central Regulatory operations team within the Fred Hutch and Fred Hutch/University of Washington Cancer Consortium’s clinical trials office, Clinical Research Support (CRS). The Operations Director is responsible for overseeing 6+ central regulatory teams, managing the enterprise-wide electronic regulatory binder system (Florence eReg), and helping to establish institutional best practices for regulatory management. The incumbent is charged with leading an org structure that supports a growing number of central regulatory teams and complex trial portfolios. Under the direction of this position, the regulatory teams perform the day-to-day regulatory management of oncology clinical trials, including investigator-initiated trials, multi-site IND trials, NCI National Clinical Trial Network (NCTN) trials, and industry-sponsored trials. The position is a key member of CRS leadership and reports directly to the VP of Clinical Research.

Responsibilities

• Oversee all aspects of Central Regulatory staffing, operations, systems, and expansion.
• Set vision and strategy for expanding central regulatory teams that include both staff recruitment and retention strategies, and portfolio expansion strategies.
• Establish and operationalize policies, Standard Operating Procedures (SOPs), and quality assurance processes that ensure program compliance; partner with CRS Compliance and Regulatory Affairs Program to align with existing policies and systems. 
• Partner with study managers to establish and maintain well-defined work flows, roles and responsibilities, and communications to ensure effective integration between regulatory and clinical operations.
• Oversee management and system support for an enterprise-wide eRegulatory and eSubject management system, Florence, including on-boarding, training, SOP management, user group engagement, trial migration, and quality control.
• Create roadmap and oversee implementation of new Florence modules, functionality, and integrations with other Consortium systems.
• Identify Consortium and Central Regulatory improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.
• Lead change management across Consortium study teams in support of increased central regulatory management; establish faculty relationships and channels of communications to keep faculty apprised of central regulatory operations.
• Form strong partnerships with disease group faculty and administrative leaders, developing standard report-outs for each centrally managed portfolio.
• Serve as Consortium lead for regulatory operations, working across teams to establish standards, leading forums, and identifying Consortium-wide improvement opportunities. Serve as liaison for external and institutional stakeholders including
• Consortium faculty and administrative leadership, sponsors, vendors, and outside organizations.
• Standardize tracking tools and dashboards to manage and communicate trial status’, submissions, timelines, and capacity, to internal and external stakeholders.
• Define and maintain