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.

Reporting to the Vice President and Chief Compliance Officer (VP CCO) and in collaboration with the compliance program directors and managers, the Senior Compliance Program Manager (SCPM) works closely with key Fred Hutch stakeholders including Enterprise Risk Management, Internal Audit, Business Development, Human Resources, Office of the General Counsel, Clinical Research Support, the Office of the Chief Data Officer, Information Security and others across the enterprise to ensure compliance with applicable laws, regulations and Fred Hutch policies. The SCPM is responsible for the creation and maintenance of the Compliance Development Program which focuses on identifying new and emerging regulatory and contractual updates that will result in material changes to enterprise operations and procedures. This includes Compliance Office strategic planning, identifying "greenhouse" and/or piloting project opportunities and interfacing with researchers, clinical and administrative leadership, and other key stakeholders. This role will include identifying and reporting on key operational metrics and developing compliance analytics reports to efficiently recommend solutions that will prioritize and mitigate enterprise compliance risks. This role will also work with other key programmatic compliance efforts as assigned by the VP CCO in accordance with state, and federal guidelines, laws and consistent with industry best practices.

Responsibilities

• Provides high-level regulatory and Compliance insight on enterprise initiatives and emerging programmatic efforts. This includes coordination, support and education to the Fred Hutch community (including researchers, clinicians, postdocs and administration).
• Serves as the primary navigator to coordinate cross-functional enterprise Compliance initiatives that involve human subjects research, data repositories, conflicts of interest, Privacy, IACUC, IRB, Fraud, Waste and Abuse, export controls and foreign influence, security, etc.
• Exercises independent judgment in providing regulatory guidance and recommendations to key stakeholders regarding enterprise initiatives. This includes assessing and identifying areas where Compliance requirements intersect and impact these initiatives in coordination with the subject matter experts within the Compliance Office.
• Performs enterprise and project-specific risk reviews, assists key research and clinical stakeholders with the development and/or review of Compliance-related policies and procedures, and assists departments in establishing monitoring mechanisms.
• Builds close working partnerships with external and internal key team members to effectively execute program priorities and, as appropriate, coordinate program initiatives with member institutions.
• Monitors and maintains legal and regulatory activity regarding applicable local, state, federal and international laws, rules, and regulations including notices and other updates from applicable government oversight agencies.Assists programmatic compliance directors with statutory interpretation and formulates strategy to meet those requirements.
• Identifies and assists with the coordination of needed Compliance resources; creates, implements, monitors, and updates project plans; facilitates meetings with the appropriate parties (both internal and external to Fred Hutch); tracks deliverables, milestones and goals.

Qualifications

MINIMUM QUALIFICATIONS:

• Master's degree in business, law or healthcare related field.
• 5-7 years of experience in legal, compliance, enterprise risk or other related experience in the research and healthcare fields.
• Advanced knowledge of federal and state research and healthcare regulations including US export control regulations and policies.

PREFERRED QUALIFICATIONS:

• Highest degree of credibility, integrity and discretion.
• Demonstrated proficiency in project management methods and tools.
• Demonstrated ability to work independently.
• Excellent written and verbal communication skills, including ability to present findings and recommendations as required.
• Microsoft Office product knowledge including Word, Excel and PowerPoint.
• Effective supervisory skills, including the ability to coach and mentor others.
• Sound decision making ability, considering all information and utilizing a big picture approach.
• Ability to collaborate with others to seek resolutions of problems.
• Ability to gather information from multiple sources to gain a thorough understanding of problems.
• Mastery of technical skills to manage integrity and compliance operations, such as ability to deploy and use compliance-related software and develop compliance metrics and reporting.
• Ability to effectively multitask in an unpredictable environment.
• Ability to innovate, develop or adopt best practices and manage change.
• Ability to think strategically about organizational risks and continuously document, improve, and streamline processes to advance the applicable compliance programs and initiatives assigned.

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 $124,488 to $196,747, 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