argenx

Product Manager

• Own the digital product vision and prioritize the backlog for Medical Affairs and Evidence Generation platforms, including Medical CRM and scientific exchange tools
• Translate scientific engagement and evidence generation needs into actionable user stories for technical teams
• Ensure digital solutions adhere to non-promotional regulations and medical integrity standards
• Drive development of tools and analytics to capture and analyze global medical insights
• Enable data-driven strategic decision-making for Medical Affairs and Evidence Generation leadership
• Steward the end-to-end user experience for Medical Affairs and Evidence Generation platforms
• Define and monitor KPIs measuring technology value and impact on scientific engagement objectives
• Provide day-to-day direction to delivery teams and align development with Medical Affairs priorities
• Serve as the primary contact for delivery teams, providing feedback and clarification on medical requirements

Digital Technology Product Owner – Medical Affairs

Operations

• Oversee operational delivery and staff within Global Patient Safety Operations in accordance with GPS vision, strategy, and regulatory requirements
• Guide internal functions and external vendors to support seamless GPS Operations
• Oversee and coordinate safety vendor and GPS teams for case triage and processing, expedited reporting, and aggregate reporting
• Coordinate with and support GPS GSL team deliverables related to case processing
• Collaborate with clinical, medical, regulatory, and other internal teams, as well as healthcare professionals, consumers, and contracted resources
• Communicate with argenx, business partners, and distributors regarding Pharmacovigilance Agreements and Safety Data Exchange Agreements
• Oversee assignment of Safety Specialist tasks and timely monitoring of GPS communications
• Identify issues and improvement opportunities and escalate appropriately
• Develop new processes and procedures and lead their implementation
• Perform activities in compliance with argenx Controlled Procedures and applicable global and local regulations
• Perform other tasks assigned by the line manager or Head of GPS

Safety Operations Manager, Global Patient Safety

Director

• Lead global MMN medical launch-readiness workstreams with cross-functional and regional teams.
• Translate MMN evidence gaps into a data-driven global evidence strategy.
• Lead medical strategy and scientific oversight of evidence-generation initiatives.
• Collaborate with Clinical Development, RWE, HEOR, and regional MAEG teams.
• Translate global strategy into locally relevant plans and integrate regional insights.
• Build partnerships with experts, healthcare organizations, and patient organizations.
• Identify and prioritize evidence and education needs across the patient journey.
• Support publication plans and medical education strategies with Scientific Communications.
• Maintain scientific and medical expertise in relevant diseases and products.
• Synthesize insights from scientific exchange, regional teams, congresses, advisory boards, and patient communities into recommendations.
• Provide medical and scientific input to study concepts, protocols, feasibility, investigator engagement, and recruitment barriers.
• Ensure medical affairs activities comply with pharmaceutical regulations and argenx policies.
• Attend national and international meetings and congresses.

Senior Director, Global Medical Affairs, Evidence Generation

Lead Generation

• Serve as the MA&EG lead on the FB-102 Asset Strategy Team
• Provide strategic guidance for development and life cycle management of FB-102
• Identify new indications based on disease biology and mechanism to maximize patient outcomes and access
• Work with Science, Clinical Development, MA&EG, and Commercial teams on lifecycle deliverables from development through commercialization
• Provide input into clinical trial protocols and study site selection
• Partner with clinical study teams to troubleshoot study issues
• Develop and execute Integrated Evidence Generation Plans throughout the product lifecycle
• Lead the FB-102 MA&EG argenx Community
• Develop and execute medical strategies involving scientific communications, publications, advisory boards, medical information, congress activities, field content, and data generation
• Communicate the asset’s development strategy and plans to the MA&EG Community
• Hire and manage indication leads as the molecule progresses
• Contribute to MA&EG strategies as a member of the MA&EG Leadership Team
• Foster an inclusive, collaborative, flexible, and empowering team environment
• Ensure medical affairs activities comply with pharmaceutical regulations and argenx policies and procedures

Medical Affairs and Evidence Generation Lead – Executive Director

Compliance

• Develop and implement robust US regulatory strategy for assigned projects
• Provide strategic, operational, and tactical regulatory input on pre-approval and post-approval activities focused on the US
• Lead and facilitate activities related to regional strategy
• Serve as primary contact with the FDA
• Manage and lead health authority interactions, briefing packages, response documents, and FDA correspondence
• Lead and oversee preparation of dossier content for INDs, BLAs, and NDAs
• Critically review submission documents for regulatory compliance
• Ensure timely, strategy-aligned responses to FDA questions
• Participate in development of labeling documents including target product profile, CCDS, and USPI
• Provide strategic regulatory input to clinical protocols, clinical and nonclinical reports, and summary documents
• Partner with medical, legal, quality, pharmacovigilance, and distribution teams
• Serve as Global Regulatory Lead on projects as needed
• Monitor, interpret, and communicate changes to the US regulatory landscape
• Monitor the competitive landscape, including regulatory precedents, labeling differences, and therapeutic-area issues

Director, Regulatory Affairs

• Develop and implement robust US regulatory strategy for assigned projects
• Provide strategic, operational, and tactical regulatory input on pre-approval and post-approval activities focused on the US
• Lead and facilitate activities related to regional strategy
• Serve as primary contact with the FDA
• Lead or participate in FDA meetings and prepare company personnel for FDA interactions
• Lead and oversee preparation of dossier content for INDs, BLAs, and NDAs
• Critically review submission documents for regulatory compliance
• Ensure timely, strategy-aligned responses to FDA questions
• Participate in labeling document development and negotiation strategies
• Provide input into clinical study design strategy
• Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input for business decisions
• Monitor, interpret, and communicate changes to the US regulatory landscape
• Monitor competitive landscape, including regulatory precedents, labeling differences, and therapeutic-area issues
• Contribute to global regulatory strategies across the product life cycle
• Advise and enable product launches and commercialization

Associate Director, Regulatory Affairs

• Serve as the MA&EG lead on the ARGX-121 Asset Strategy Team
• Provide strategic guidance for development and lifecycle management of the clinical asset
• Identify new indications based on disease biology and mechanism to maximize patient outcomes and access
• Collaborate with Science, Clinical Development, MA&EG, and Commercial teams on lifecycle deliverables
• Provide input into clinical trial protocols and study site selection
• Partner with clinical study teams to troubleshoot study issues
• Develop and execute Integrated Evidence Generation Plans throughout the product lifecycle
• Lead the ARGX-121 MA&EG community
• Develop and execute medical strategies through scientific communications, publications, advisory boards, medical information, congress activities, field content, and data generation
• Communicate regularly about the asset’s development strategy and plans
• Hire and manage indication leads as the molecule progresses
• Contribute to MA&EG strategies as a member of the MA&EG Leadership Team
• Foster an inclusive, collaborative, flexible, and empowering team environment
• Ensure medical affairs activities comply with pharmaceutical regulations and argenx policies and procedures
• Report to the Global Head, Medical Affairs & Evidence Generation

Medical Affairs and Evidence Generation Asset Lead – Executive Director

Head of Department

• Lead and organize a team of HEOR scientists and specialists developing value evidence for a large and growing portfolio
• Lead and maintain HEOR evidence generation plans with RWE, Clinical Development, Regulatory, MA&EG, Market Access, and Commercialization
• Develop strategic value evidence generation plans and execute analyses, timelines, and budgets
• Lead HEOR organizational evolution to support a growing commercialization organization and upcoming launches across multiple markets
• Partner with Market Access to align local market evidence generation needs and priorities
• Identify, select, and execute value-evidence projects with internal stakeholders and external experts
• Monitor developments affecting stakeholder needs and direct value-evidence planning
• Lead evidence dissemination through high-quality publications with investigators, HCPs/KOLs, and patient advocates
• Partner with MA&EG, RWE, and Patient Advocacy to engage relevant HCPs/KOLs and Patient Advocacy Groups
• Contribute to the MA&EG Leadership Team and support community vision and people development
• Participate in the argenx government relations community and execute relevant evidence generation
• Develop and deliver presentations to external stakeholders when requested
• Conduct internal HEOR training for argenx colleagues
• Develop long-term strategy for HEOR capability excellence, including scope, budget, timelines, and evidence dissemination