Director Risk and Compliance Operations

Intellia Therapeutics, Inc.•Cambridge, MA

4d•$214,137 - $261,723

About The Position

As we continue our exciting evolution, we are looking for a strategic leader to help further build and refine our global compliance program as we prepare for commercialization. Reporting to the VP Risk and Compliance, the Director Risk and Compliance Operations will lead the operations of Intellia’s Enterprise Risk & Compliance Programs ensuring that systems, processes, and reporting obligations are effectively implemented and maintained. The position emphasizes execution, operational excellence, and project management across monitoring, transparency reporting, training, policy administration, and investigations to help ensure compliance with applicable laws, regulations, and company policies. This is an exciting opportunity for a passionate builder, someone who thrives in fast-paced, high-growth environments and is energized by the challenge of shaping a program. The ideal candidate is ready to roll up their sleeves, partner cross-functionally, and grow.

Requirements

Ability to build and maintain professional relationships with internal stakeholders.
Demonstrated experience leading highly complex initiatives with significant risk and complexity, leveraging strong cross-functional relationships and influencing skills.
Ability to manage multiple priorities in a fast-paced environment with flexibility, commitment to teamwork, and willingness to adapt assignments to meet the Company’s needs.
Ability to partner cross-functionally with IT, Finance, Legal, and business stakeholders to drive adoption and timely delivery of system/process enhancements, including communicating with senior/executive leaders as a functional area expert.
Strong project/program management experience, including managing scope, timelines, risk/issues, and cross functional stakeholders.
Strong analytical and problem-solving skills with strong attention to detail and accuracy; ability to translate complex data/process topics into clear insights and recommendations.
Strong presentation and communication skills (written and verbal), including creation of executive-ready materials and facilitation of working sessions.
Manages sensitive and confidential matters with discretion and sound judgment.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) and familiarity with analytics and work management tools (e.g., Power BI, Smartsheet, Microsoft Project).
Demonstrated knowledge of regulatory/compliance requirements applicable to corporate compliance (e.g., Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practice Act, and state price transparency laws and regulations), experience with healthcare compliance programs a plus.
Demonstrated ability to design and govern compliance systems and system-enabled processes, including defining controls, translating requirements into system/process configurations, and ensuring sustainable operating procedures.
Strong understanding of data governance concepts and ability to establish data quality standards, definitions, and reporting requirements to support reliable analytics and decision-making.
Learning agility: ability to quickly learn new subject areas and support emerging priorities as directed.
Produces high-quality work with minimal oversight from manager.
Bachelor’s Degree in business, finance, life sciences, healthcare, information systems or related field with 12+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech) or, Master's Degree/JD with 10+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech).
10+ years of experience leading compliance systems and process governance, requirements definition, testing/UAT, implementation and continuous improvement and making decisions and recommendations regarding organizational practices, policies and systems.
10+ years of experience with data governance and operational reporting/analytics (e.g., dashboards, KPIs, data quality).

Nice To Haves

Experience with OneTrust and Diligent are a plus.

Responsibilities

Compliance lead for systems, process governance, and reporting enablement, with responsibility for shaping scalable operational solutions that support effective Risk and Compliance programs, including advancing risk and compliance systems roadmaps and overseeing enhancements and release readiness, and ensuring process are scalable, sustainable and aligned with business and regulatory expectations.
Lead complex cross-functional initiatives, improving data quality and process performance, and addressing operational and regulatory challenges with thoughtful, practical solutions.
Oversee and scale internal investigations process, including program process for case intake, evidence collection, case tracking and tracking of remediation activities and support ongoing monitoring of corrective actions.
Support the corporate ERM and audit programs aligned to the compliance risk assessment.
Own compliance tooling strategy and operations (case management, approvals workflow, third-party due diligence tools, transparency systems, LMS interfaces as needed, analytics).
Lead vendor governance and performance management for outsourced compliance services.
Provide leadership for data governance across compliance-owned systems and datasets by establishing quality standards, definitions, documentation, and control expectations.
Enable more effective reporting and analytics by improving data completeness, accuracy, and usability and by partnering with stakeholders to define business requirements for dashboards, extracts, and other reporting outputs.
Play a leadership role in building and maintaining a third-party risk management program for compliance risk, including risk-based intake, due diligence, governance, onboarding, renewal, and termination processes.
Partner across functions to embed appropriate compliance controls into internal and vendor lifecycle activities and helps ensure that operational design keeps pace with evolving business needs and regulatory expectations.
Work across functions and levels of the organization to influence decisions, align priorities, and move initiatives forward.
Handle sensitive and confidential matters with discretion and sound judgment.
Performs other related duties as assigned.