Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Assistant Director of Regulatory Operations is responsible for overseeing the central regulatory operations team in the Fred Hutch and Fred Hutch/University of Washington Cancer Consortiums clinical trials office, Clinical Research Support (CRS). The Assistant Director is responsible for a broad scope of operations including management of the institutions electronic regulatory binder system (eReg), setting regulatory operations best practices, and oversight and expansion of the regulatory teams. The position provides an opportunity for rapid growth as the incumbent is charged with establishing an org structure that supports a growing number of central regulatory teams that the position will oversee. The current portfolio includes more than 100 active studies and is expected to more than double. Under the direction of this position, the regulatory teams manage the day-to-day regulatory documentation 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 Director of Clinical Research Operations.
Set vision and strategy for expanding central regulatory teams that manage regulatory submissions and documentation throughout a trial life cycle. The trial portfolio is primarily oncology and includes multi-site investigator-initiated IND trials, industry trials, NCTN studies, and single-site investigator-initiated trials.
Establish operating model for newly-implemented eReg system, Florence eRegulatory Binder System, including onboarding, user group engagement, trial migration, and quality control. The system currently supports more than 300 users
In partnership with the Fred Hutch / CRS Compliance and Regulatory Affairs Program, define regulatory team and Consortium best practices for regulatory management; create and maintain Standard Operating Procedures (SOPs) and ensures program compliance with the SOPs
Lead change management across Consortium study teams in support of increased central regulatory management; partner with CRS Medical Director to establish faculty relationships and consistent communications
Define and report-out program metrics and key performance indicators for institutional and Consortium leadership, and faculty
Manage multiple regulatory teams and plan workload management, resources and hiring strategy for expanding portfolio
Form and execute plan to staff growing team by developing staff and offering professional growth opportunities within the regulatory group
Identify Consortium and program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams
Bachelors degree (Masters degree preferred)
Minimum of 5 years of regulatory experience in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials
At least 2 years professional experience managing senior level personnel. Strong leadership skills are required to lead clinical resources through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to:
manage a diverse team, think creatively and globally, project future needs, and be attuned to the day-to-day division operations
effectively lead individual teams as well as act collaboratively across an organization
Develop and document procedures through strong project management and business analysis skills, methodologies and best practices with demonstrated ability to standardize operations and processes
Establish timelines, benchmark accountability and oversee program and project budgets;
Analyze data and apply an analytical framework to decision making
Sustained, proven ability to think analytically, problem solve and use independent judgment
Excellent communication (written and oral), customer service, collaboration, problem solving and interpersonal skills
Superior presentation and organizational skills with an attention to detail mindset
Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders, including technical and non-technical personnel at various levels in the organization
Advanced knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations
Clinical research-related certification preferred
Experience working with electronic regulatory solution or Clinical Trial Management System
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at email@example.com or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.