Associate Director, Ethics & Compliance - Risk Assessment and Monitoring

Associate Director Ethics & Compliance (E&C), Risk Assessment And Monitoring

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. Argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Associate Director Ethics & Compliance (E&C), Risk Assessment and Monitoring is a key member of our E&C team who will support our operations and be based in Boston (US) or Ghent (Belgium). This is an opportunity to further develop a best-in-class global E&C program as a member of a dynamic team poised for growth, with cross-functional work with teams in other regions. We are seeking a visionary leader to redefine how risk is assessed and monitored in the biotech industry. This role goes beyond traditional complianceit is about building predictive, adaptive, and intelligent systems that anticipate risk, drive ethical decision-making, and enable business innovation.

Roles And 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

Skills And Competencies

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.

Required travel for this role is around 20%

Education, Experience And Qualifications

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.