Head of Medical Safety Assessment

argenx

1d•Remote

About The Position

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 Head of Medical Safety Assessment serves as a senior medical leader for Global Patient Safety with direct accountability for medical safety assessment across development assets and geographies. The role sets the cross-portfolio medical safety assessment strategy and ensures consistent, high-quality benefit–risk evaluation, safety decision-making, and safety communications throughout the product lifecycle. The role provides functional and people leadership to a combined global team of Safety Physicians and Safety Scientists and is accountable for excellence in the core delivery of patient safety, including signal detection and management, risk management, and aggregate safety reporting. The Head of Medical Safety Assessment acts as a primary medical point of escalation for complex or non-routine safety issues and provides expert guidance to asset, development, and medical teams. In alignment with argenx leadership competencies, this leader demonstrates enterprise thinking, empowers teams through clear decision rights and accountability, and continuously challenges the status quo. The role establishes a forward-looking vision for how Medical Safety Assessment and Global Patient Safety must evolve to leverage emerging technologies and data sources—including artificial intelligence, real-world data, advanced analytics, and digital and wearable technologies—to enable proactive, data-driven, and patient-centric safety surveillance and benefit–risk management. This role will interface with the following: Internal: Global Patient, Global Regulatory Sciences, Clinical Development, Biostatistics / Quantitative Sciences, Medical Affairs, HEOR, RWE, Quality, Legal, Commercial (as appropriate). External: Health Authorities, Independent Data Monitoring Committees, Key Opinion Leaders and External Experts, strategic partners, vendors, and CROs.

Requirements

MD or equivalent medical degree required.
Minimum of 15 years of pharmaceutical or biotechnology industry experience.
At least 10 years of leadership experience in pharmacovigilance and medical safety.
Demonstrated experience overseeing leading innovation initiatives within a patient safety organization.
Experience with signal management, aggregate safety reports, and risk management activities.
Proven track record leading global, multidisciplinary medical safety teams.
Experience interacting with Health Authorities on complex and strategic safety topics.
Proficiency with standard business tools (e.g., Microsoft Office).
Fluency in written and spoken English.

Nice To Haves

Experience implementing novel technologies and leveraging emerging data sources relevant to patient safety is strongly preferred.

Responsibilities

Senior medical leader for global medical safety assessment for development assets, setting cross-asset strategy, standards, and scientific expectations while demonstrating enterprise thinking beyond functional boundaries.
Provide direct line management, mentoring, and coaching to a global team of Safety Physicians and Safety Scientists, fostering an empowered, accountable, and high-performing organization.
Act as the senior medical escalation point for complex, high-impact, or non-routine safety issues.
Ensure consistency, quality, and scientific rigor in signal detection, safety labeling strategy, risk identification and management, and aggregate safety reporting (e.g., DSURs, PSURs/PBRERs, SSRs).
Provide expert medical judgment and leadership in benefit–risk assessments and safety decision-making across the portfolio.
Provide strategic safety input and messaging to asset, development, and medical teams.
Represent Medical Safety Assessment in safety governance bodies and ensure safety decisions and their rationale are clearly documented.
Partner closely with Global Regulatory Sciences to support Health Authority interactions, safety queries, inspections, and audits.
Define and drive the Medical Safety Assessment strategy for adoption of artificial intelligence, real-world data, advanced analytics, and digital technologies germane to the mission of GPS.
Collaborate with Safety Systems, Digital Technology, Quantitative Sciences, and PV Quality to ensure innovative approaches are compliant, scalable, and embedded in core processes.
Represent Global Patient Safety as a senior medical subject-matter expert in audits and inspections, as required.
Contribute to cross-company initiatives, including safety methodology development and business development / due diligence activities.
Perform other tasks as required to support departmental objectives