Please apply for this role at:
https://careers-fhcrc.icims.com/jobs/26616/director%2c-regulatory-operations/job
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.
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.
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.
Qualifications
Required:
Bachelor’s degree in a related field.
Minimum of 8 years of regulatory experience with a minimum of 5 years regulatory experience in the conduct of oncology interventional, treatment, and/or FDA-regulated clinical trials. Minimum of 3 years professional experience managing senior level personnel.
Ability to manage a diverse team, think creatively and globally, project future needs, and be attuned to the day-to-day department operations.
Ability to effectively lead individual teams as well as act collaboratively across an organization.
Strong leadership skills are required to lead clinical resources through periods of growth, change and time pressure.
Advanced knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
Preferred:
Master's degree in a related field.
Clinical research-related certification.
Experience at an NCI-designated cancer center.
The annual base salary range for this position is from $156,748.80 to $261,206.40
Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.