argenx

Operations

• Manage the execution of MRC operations including agenda management, meeting facilitation, VEEVA PromoMats and MedComms use & documentation, and quality control processes
• Support the development and maintenance of training content, process documentation, and reference materials for commercial and medical material review
• Support training sessions for the MRC community to ensure understanding and alignment on operational processes and technology platforms for material review
• Provide daily support and direction to vendor and internal partners on MRC execution and adherence to established processes
• Manage volume projections and collaborate with stakeholders to address material volume fluctuations and capacity needs
• Ensure compliant adherence to SOP for material review, tracking compliance, and facilitating remediation as necessary
• Collaborate with internal teams to promote innovation, share best practices, and identify areas for operational improvement and efficiency

Manager, MRC Operations

Scientist

• Conduct continuous review and analysis of aggregate safety data from clinical trials, post-marketing individual case safety reports (ICSRs), literature, registries, and external databases.
• Identify data, analytical, or process improvements that increase the likelihood of detecting a signal or decrease the time to signal detection.
• Leverage data, analytics, visualization, and AI-supported outputs to enhance signal detection, aggregate safety review, and benefit–risk assessment.
• Critically review and interpret outputs from safety databases, analytics, and AI-enabled tools, applying appropriate scientific judgment and awareness of data limitations, bias, and confounding.
• Contribute to the design, testing, and continuous improvement of data-driven and automated safety-surveillance workflows, in alignment with quality, validation, and regulatory requirements.
• In conjunction with safety physician team members, identify opportunities to increase knowledge of patient treatment, drugs and interactions, and treatment pathways that drive actions and decisions to ensure the safe use of argenx medicines.
• Perform medical coding checks, case series reviews, and standardize MedDRA search strategies.
• Define data acquisition strategy, methodology, and approach for safety evaluations.
• Assist in the assessment and management of medical safety data, and in the development and execution of safety signal and benefit–risk management strategies.
• Contribute and perform analysis and participate actively in safety governance meetings.
• Lead and participate in the planning, preparation, drafting and review of periodic safety reports.

Safety Scientist

Affiliate Manager

• Develop and execute the overall business strategy for CEE, MENA and LATAM region in alignment with global corporate objectives.
• Lead brand planning processes with partners and ensure high-quality execution
• Support forecasting, annual operating plans, and long-rage business planning
• Identify growth opportunities and commercialization priorities
• Act as primary commercial contact for distributor and commercialization partners
• Lead governance meetings and business reviews
• Monitor KPIs and partner performance
• Drive accountability and capability building
• Co-develop and lead business cases for market expansion, partnerships, and new geographies.
• Optimize partner models and commercialization approaches the Argenx Way.
• Assess investment requirements, risks, and ROI
• Lead launch readiness and execution activities in partner markets
• Coordinate cross-functional launch planning.
• Support launch sequencing in close alignment with pricing and monitor performance.
• Ensure high-quality partner-led commercial execution.
• Collaborate closely with Medical Affairs, Market Access, Regulatory, Supply Chain, Finance, Legal, Compliance and Global Commercial teams.
• Connect unit between global marketing teams, the EPM LT and the partners
• Lead, mentor, and develop the cluster Launch Excellence Leads to drive engagement, growth, and results.
• foster a culture of collaboration, innovation, and accountability among teams.
• Conduct thorough market analysis, competitive assessments, and customer insights to identify trends and opportunities.
• Utilize market intelligence to make informed decisions and adapt strategies.
• Ensure all activities comply with local regulations and argenx standards.

Commercial Lead Partner Markets

Clinical Operations

• Responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset.
• Co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP).
• Ensures that all relevant information from all functions within the AST and CDT are brought to the table.
• Responsible for the clinical development strategy, ensuring execution of the CDP once endorsed by the AST.
• Oversees the clinical trial budgets, contributes to timeline and resource requirements and provides input to the financial CDT planning.
• Partners with the PM to review status and impact of change and to discuss options to resolve issues and mitigate risks.

Clinical Operations Development Lead

Manager

• Drive the growth of the GPS Quality Management function
• Drive & Implement the Comprehensive Training Program
• Manage GPS Procedural Document activities
• Actively participate in and coordinate GPS Audit & Inspection Readiness, Support & Management
• Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development)
• Coordinate and manage GVP Audit & Inspection activities
• Engage in internal global GVP audit program and inspection readiness activities
• Prepare GPS team members on inspection readiness activities
• Assess GPS issue management trends and develop/implement actions plans to mitigate systemic causes
• Guide the GPS team to determine root cause of issues to avoid recurrence
• Develop, expand, and deliver the pharmacovigilance training program
• Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.

GPS Quality Manager

Medical Science Liaison

• Engage with Key Opinion Leaders at academic and community centers
• Support KOL development and advocacy while collaborating with cross-functional teams
• Identify clinical trial sites and opportunities for research
• Conduct timely and informative scientific/medical exchanges with external stakeholders
• Develop and maintain scientific expertise for relevant diseases and products

General

• Develop and maintain the highest scientific and medical expertise of all relevant diseases, products, development plans
• Identify and develop productive collaborations with Key Opinion Leaders and stakeholders
• Ensure timely and informative scientific/medical exchanges with external stakeholders
• Deliver high quality scientific/medical education in various settings
• Ensure all external interactions are conducted according to compliance policies
• Identify potential investigators and centers for participation in clinical research
• Support feasibility assessments and site initiation for clinical trials

Medical Science Liaison, Multi-Specialty

• Lead and coordinate combination product-related activities across functional teams and projects
• Act as the central point of contact for combination product development across CMC, Regulatory, Quality, Clinical Supplies, and external partners
• Facilitate alignment of device strategy across multiple programs, ensuring consistency and scalability
• Oversee design, industrialization, and lifecycle management of combination products including prefilled syringes and auto-injectors
• Coordinate formative and summative human factors studies in collaboration with internal teams and external providers
• Contribute to regulatory submissions including authoring and reviewing device sections

Device Expert Director – Technical Operations

Compliance

• 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
• Developing, implementing, and enhancing a dynamic monitoring framework
• Ensure timely, high-quality monitoring reports with executive summaries, root cause analysis, and clear recommendations
• Maximize collaboration with external partners to oversee the execution of monitoring activities
• Drive strategy and plan for live monitoring activities
• Implement robust processes to ensure the quality, integrity, and traceability of data used in risk assessments
• Serve as the primary compliance contact for Internal Audit
• Oversee third-party risk management activities
• Support gap assessment efforts

Associate Director, Ethics & Compliance – Risk Assessment and Monitoring

Director

• Own and define the US insights strategy and learning agenda
• Proactively identify key business questions and shape decision-making across the rheumatology portfolio
• Act as a strategic thought partner to cross-functional and senior leadership
• Define the insights roadmap and ensure insights are translated into actionable recommendations
• Partner with cross-functional and global commercialization partners to identify market intelligence needs
• Ensure methodological rigor and best practices across all qual & quant, primary & secondary research activities
• Synthesize insights across multiple data sources to deliver a unified, integrated view of the market

Associate Director, US Commercial Insights – Rheumatology

• Define and execute U.S. regulatory strategy for promotional materials across the product lifecycle
• Serve as the primary regulatory authority for FDA advertising and promotion compliance
• Lead regulatory oversight and approval for promotional and medical education materials
• Drive a future focus through a digitally enabled, AI-forward regulatory capability
• Interpret enforcement actions to inform internal standards
• Partner cross-functionally to enable compliant product differentiation and value communication
• Provide regulatory input into launch readiness, messaging frameworks, and lifecycle strategies
• Lead and scale U.S. Ad/Promo capabilities to support multiple launches across therapeutic areas
• Future-proof the MRC/MMRC process to align with automation