Role Description
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. 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
-
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.
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.
Qualifications
-
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.
-
Experience implementing novel technologies and leveraging emerging data sources relevant to patient safety is strongly preferred.
Requirements
-
Senior medical leadership, committed to innovation, and strategic influence aligned with the argenx ways of working.
-
Deep expertise in signal management, benefit–risk assessment, risk management, and aggregate reporting.
-
Strong knowledge of global pharmacovigilance regulations and safety governance.
-
Enterprise mindset with the ability to balance scientific rigor, patient-first thinking, and business impact.
-
Demonstrated ability to empower teams, foster accountability, and develop senior experts.
-
Strong communication skills with the ability to influence across functions and leadership levels.
-
Scientific curiosity, analytical rigor, and comfort navigating ambiguity and complexity.
-
Interest in and aptitude for applying advanced technologies, data, and analytics to medical safety.
-
Proficiency with standard business tools (e.g., Microsoft Office).
-
Fluency in written and spoken English.
Benefits
-
Annual base salary hiring range: $292,000.00 - $401,500.00 USD.
-
Participation in short-term and long-term incentive programs.
-
Comprehensive benefits package, including retirement savings plans and health benefits.