To strengthen our
Safety Evidence and Insights team, we are seeking an experienced pharmaceutical professional who can connect
medical science, safety evidence and business strategy across the product lifecycle.
The Safety Evidence (Medical) Lead will generate and translate safety evidence into insights that
differentiate argenx therapies, strengthen understanding of their benefit-risk profile, and inform evidence and product strategy. The role combines medical/scientific expertise, data analytics and strategic thinking, integrating evidence from internal safety data, real-world data, post-authorization studies, medical literature and other relevant sources.
This role does not simply generate safety evidence. It identifies where safety evidence can create meaningful scientific and strategic differentiation, then builds the evidence needed to realize that opportunity.The successful candidate will operate as both a
strategic thought partner and hands-on evidence leader, bringing deep understanding of drug development, safety science and the broader competitive environment.
We are looking for candidates based in
Belgium, Switzerland or US (EST time zone.Purpose of the RoleThe Safety Evidence (Medical) Lead will:
- Identify opportunities for strategic differentiation by assessing the safety profiles of argenx products in the context of competitors and the evolving treatment landscape.
- Identify critical safety evidence gaps and translate them into evidence-generation priorities.
- Shape and contribute to Integrated Evidence Generation Plans (IEGPs), ensuring safety evidence supports meaningful scientific and strategic questions.
- Provide medical interpretation and contextualization of safety evidence across multiple data sources, converting complex data into decision-relevant insights.
- Provide safety expertise to cross-functional teams.
- Lead late-stage safety-focused studies, including real-world studies.
- Translate evidence into clear scientific narratives for internal and external stakeholders.
Key Responsibilities:Strategic Safety Intelligence & Differentiation
- Continuously evaluate emerging safety evidence for argenx products and relevant competitors to identify differentiating attributes, evidence gaps and emerging opportunities.
- Integrate safety, clinical, real-world and scientific evidence to develop a holistic understanding of product safety profiles.
- Translate complex evidence into actionable insights that inform evidence strategy and cross-functional decision-making.
Evidence Strategy & Generation
- Partner with RWE, Medical Affairs, GPS, Regulatory, HEOR, Clinical Development, Clinical Science and Biostatistics to shape evidence-generation priorities and IEGPs.
- Lead the strategy, design, interpretation and scientific communication of safety-focused studies, including PASS.
- Provide medical and safety leadership for the interpretation of safety endpoints and outcomes in real-world studies.
- Ensure evidence generation addresses questions that matter to patients, healthcare professionals and other relevant stakeholders.
Scientific Leadership & Influence
- Serve as a medical and scientific thought partner on safety evidence across functions.
- Develop compelling scientific narratives that contextualize safety findings and articulate their relevance for argenx therapies.
- Partner with Scientific Communications to integrate safety evidence into publication strategies.
- Engage external experts and KOLs to strengthen evidence strategies and scientific understanding.
Skills & Competencies:- Strong strategic, medical and scientific judgment, with the ability to connect evidence to broader product and business questions.
- Ability to integrate complex safety information across multiple data sources and distinguish meaningful signals and insights from data noise.
- Strong understanding of drug development and evidence generation across the product lifecycle.
- Ability to influence and collaborate effectively in a complex, cross-functional environment.
- Strong scientific communication skills, with the ability to translate complex evidence into clear, decision-relevant narratives.
- Intellectual curiosity and a proactive, solution-oriented mindset.
- High digital and analytical literacy, including the ability to critically interpret dashboards, analytical outputs and AI-generated insights and apply appropriate medical judgment.
Education & Experience:- Medical degree preferred; PhD, PharmD or comparable scientific qualification considered with demonstrated expertise in immunology and/or patient safety.
- Strong medical/scientific background with pharmaceutical or biotechnology experience in strategic Medical Affairs, late-stage Clinical Development, Safety Evidence, Patient Safety or related evidence-generation roles.
- Minimum 5 years' experience leading scientific or clinical projects/studies.
- Working knowledge of GCP and GVP.
- Ability to travel as required, up to 20%.
Candidates must be based in
Belgium, Switzerland or US (EST time zone) to be considered for this role.
