Head of Medical Safety Assessment

arGEN-X N.V.

Job Overview

Location

United States - Remote

Job Type

Full-time

Full Job Description

📋 Description

• 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, setting cross-portfolio medical safety assessment strategy and ensuring 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, accountable for excellence in core delivery of patient safety, including signal detection and management, risk management, and aggregate safety reporting, and acts as a primary medical point of escalation for complex or non-routine safety issues.
• argenx is building a new kind of biotech company rooted in science-based innovation, committed to transforming immunology and delivering medicines that help autoimmune patients get their lives back, with a pipeline led by VYVGART and a culture focused on inspiring growth in science, partnerships, and people.
• The person in this role can establish a forward-looking vision for Medical Safety Assessment by leveraging emerging technologies such as 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, while developing senior experts and influencing cross-functional teams.

🎯 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.
• Proven track record leading global, multidisciplinary medical safety teams.
• Experience interacting with Health Authorities on complex and strategic safety topics.

🏖️ Benefits

• Eligibility to participate in short-term and long-term incentive programs.
• Comprehensive benefits package including retirement savings plans and health benefits.
• Opportunity to work remotely within the United States.
• Access to innovative projects involving artificial intelligence, real-world data, and advanced analytics in patient safety.
• Inclusive work environment with equal opportunity employment practices.
• Support for reasonable accommodations during the application and interview process.

Skills & Technologies

Remote

Degree Required

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arGEN-X N.V.

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About arGEN-X N.V.

arGEN-X is a global immunology company focused on developing a pipeline of antibody-based therapies for patients suffering from severe autoimmune diseases and cancer. The company leverages its powerful FcRn antagonist technology and broad pipeline to address a range of debilitating conditions. arGEN-X is committed to transforming the standard of care for these diseases and improving patient outcomes. Their approach involves deep scientific understanding of immunology and a dedication to innovation, aiming to deliver breakthrough treatments to those in need. They are driven by a mission to make a meaningful difference in the lives of patients worldwide.

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