Research Manager, Central 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 Manager leads a team of regulatory coordinators and regulatory assistants within the Fred Hutch and Fred Hutch/University of Washington Cancer Consortium's central clinical trials office, Clinical Research Support (CRS). The operations manager is responsible for the planning and execution of regulatory oversight for the Breast Medical Oncology, Global Oncology, and other specialized Oncology clinical research portfolios. The portfolio includes investigator-initiated trials, multi-site IND trials and industry-sponsored trials.
Responsibilities

• Oversee day-to-day operations of a central team that is responsible for managing regulatory submissions and maintaining all regulatory files for designated clinical research portfolios ensuring quality, timeliness and compliance with applicable policy and regulations.
• Collaboratively develop vision and strategy for building and managing a regulatory team that can effectively support the research program goals.
• Oversee the hiring and resource planning within the Central Regulatory team to align with the size, complexity, and growth of trial portfolios.
• Develop and maintain standard operating procedures (SOPs), and ensure staff adherence to SOPs through training, oversight, and QC of team's work.
• Establish a close working relationship with study managers, PIs, and other key program personnel to maintain defined processes, and roles and responsibilities across teams and operational areas.
• Form strong partnerships with disease group faculty and administrative leaders, developing standard report-outs for each research program's portfolio.
• Utilize central systems, tracking tools, and dashboards to manage workload, performance, and capacity.
• Identify opportunities for operational improvements, make recommendations to leadership, and oversee changes as necessary. Develop systems for continuous monitoring.
• Form and execute plans to staff a growing team by developing staff and offering professional growth opportunities.
• Work collaboratively with fellow Research Managers create and execute on a vision for Central Regulatory growth and influence.
• Track and report-out team metrics and key performance indicators to department and research program leadership.

Qualifications

• Bachelor's degree/equivalent qualification or experience
• 3 years' experience managing regulatory documentation. Experience managing oncology industry-sponsored and investigator-initiated trials preferred.
• At least 2 years' experience directly or indirectly managing personnel and training team members.
• Regulatory related certification preferred.
• Knowledge of FDA regulations, GCP guidelines, and other applicable regulations
• Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders.
• Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs)
• Experience working with a clinical trial management system (CTMS), and electronic regulatory binder system preferred.
• Excellent oral and written communication skills
• This is a majority remote position supporting a majority remote staff, must have effective communication, trouble-shooting, change management and conflict resolution skills within a remote setting.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
The annual base salary range for this position is from $94,702 to $149,656, and pay offered will be based on experience and qualifications.
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).
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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700.