argenx · 6 hours ago
Associate Director, Ethics & Compliance - Risk Assessment and Monitoring
United States
Full-time
Remote
Lead/Staff, Director/Executive
10+ years expargenx is a biotech company transforming immunology and delivering medicines for autoimmune patients. The Associate Director of Ethics & Compliance will develop a global E&C program, focusing on innovative risk assessment and monitoring strategies to ensure compliance and ethical decision-making within the organization.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Design and implement a next-generation Risk Assessment and Mitigation Plan (RAMP) framework using AI, machine learning, behavioral patterns, and data analytics to proactively identify emerging compliance risks
Collect and analyze data to identify emerging global risks, control gaps, fraud, or non-compliance, and deliver clear reports and dashboards to inform strategic risk decisions and assess compliance controls
Developing, implementing, and enhancing a dynamic monitoring framework, including collaboration with Internal Audit and other teams that regularly audit argenx business activities such as Quality, Finance and those of our third-party partners
Ensure timely, high-quality monitoring reports with executive summaries, root cause analysis, and clear, actionable recommendations, leveraging improved tools and processes for continuous enhancement
Maximize collaboration with external partners to oversee the execution of monitoring activities by embracing the argenx ways of working, fostering shared accountability
Innovatively explore and expand the scope of monitoring in emerging risk areas such as trade sanctions, social media, data privacy, digital engagement, and AI-driven business processes
Drive strategy and plan for live monitoring activities such as field ride-alongs, speaker programs, and advisory board meetings to assess compliance with company policies, identify potential risks, and ensure adherence to regulatory requirements
Implement robust processes to ensure the quality, integrity, and traceability of data used in risk assessments and monitoring activities
Serve as the primary compliance contact for Internal Audit, supporting planning, documentation review, testing, and remediation efforts
Support compliance investigations, contributing to root cause analysis and outcome reporting
Oversee third-party risk management activities, including anti-bribery/anti-corruption due diligence, background checks, and trade sanctions screening, to ensure compliance with compliance standards and regulatory requirements
Support gap assessment efforts to ensure completion of actions derived from maturity assessments, ensuring transparency, consistency, and defensibility of risk-related decisions
Willingly assist LCIP team with projects and activities in areas outside of own primary areas of responsibility as needed to achieve corporate objectives
Qualification
Required
Bachelor's or Master's degree in a relevant field (e.g., Life Sciences, Business, Data Science, Law, or related discipline)
10+ years of experience in compliance, risk management, audit, or related roles within the life sciences sector
Proven experience designing and executing risk assessment frameworks, ideally leveraging AI, machine learning, and advanced analytics
Excellent analytics skills and experience with data analysis software, including building and maintaining dashboards, repositories, and reporting tools for compliance and risk monitoring
Ability to synthesize large volumes of compliance data, KPIs, and external regulatory intelligence into actionable insights
Deep understanding of global bio-tech compliance, regulatory frameworks, and industry best practices
Demonstrated ability to monitor, interpret, and integrate external regulatory trends and industry developments into compliance strategy
Experience supporting audit and inspection readiness, including documentation protocols and remediation efforts
Strong cross-functional collaboration skills, with a track record of working effectively with Legal, Internal Audit, Medical, Commercial, and other business partners
Demonstrated ability to work autonomously, prioritize effectively, and deliver results with minimal supervision
Excellent written and verbal communication skills, including the ability to prepare executive summaries, present findings, and deliver compliance training
Experience driving change and innovation in compliance or risk management functions
Benefits
Short-term and long-term incentive programs
Comprehensive benefits package
Retirement savings plans
Health benefits
Company
argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$3.75BKey Investors
Forbion Capital Partners
2023-07-18Post Ipo Equity· $1.1B
2022-03-23Post Ipo Equity· $700M
2021-02-02Post Ipo Equity· $999.38M
Leadership Team
Karen Massey
Chief Operating Officer
Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
Recent News
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2026-01-16
2026-01-16
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