
argenx
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United in our commitment to improve the lives of patients
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• 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.
• 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.
Role Description To support the continued growth of Partner Markets (PM), argenx is seeking an experienced and entrepreneurial Commercial Lead to drive commercial excellence across a diverse portfolio of distributor-led and partner markets. The geographic span includes but is not limited to Latin America, Central Eastern Europe, Middle East and North Africa. The Commercial Lead will serve as the primary commercial interface between argenx and assigned regional partners, ensuring successful commercialization of VYVGART and future pipeline assets. The role combines strategic leadership, business development, launch excellence, partner governance, and execution oversight to maximize patient impact and sustainable business growth. The role requires close collaboration with Medical Affairs, Market Access & Pricing, Regulatory, Supply Chain, Finance, Legal, Compliance, and Global Commercial teams. The Commercial Lead will be a member of the EPM Leadership Team, reporting to the Head of EPM. Qualifications - 15+ years’ experience in biopharmaceutical industry - Strong marketing and sales experience is a must - Proven experience as a Commercial Lead / BUD or in a senior commercial leadership role with a track record of successfully managing business operations and driving growth - Strong experience in specialty care, immunology, neurology, rheumatology, oncology, rare diseases or innovative therapeutics - Emerging markets and distributor management experience is a must (GCC, CEE and/or Latam) - Having worked for a distributor is a strong plus - Ideally mid-size to small biotech/pharma experience - Proven track record in launches, brand planning, and partner management - Strategic thinker with strong business acumen - Strong analytical and problem-solving skills - Result driven and proactive personality, passionate about overachieving - Influencing and stakeholder management capabilities - Entrepreneurial and growth mindset with execution focus - Ability to thrive in complex multicultural environments - Passion for improving patient outcomes Requirements - Bachelor's degree in Life Sciences, Business, or a related field - Demonstrated ability to develop and execute business strategies, including market entry and expansion - Excellent leadership and team-building skills, with the ability to inspire and motivate diverse teams - Analytical mindset with strong problem-solving abilities and the capacity to make data-driven decisions - Effective communication, negotiation, and relationship-building skills - Fluency in English is required; proficiency in Spanish or Arabic is a plus - Willingness to travel regularly within the region and internationally as needed Benefits - This job is eligible to participate in our short-term and long-term incentives program - The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting - Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills - argenx may pay more or less than the posted range and this range may be modified in the future
Medical Science Liaison, Multi-Specialty
argenxUnited in our commitment to improve the lives of patients
• 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
• Expert medical resource and argenx ambassador • Develop and continuously maintain the highest scientific and medical expertise of all relevant diseases, products, development plans, and be acknowledged internally and externally as an expert • Identify and develop productive collaborations with Key Opinion Leaders, other important customers and stakeholders, including professional organizations • Support the development and implementation Strategic Territory Plans to advance Medical Affairs strategy • Maintain a high level of knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of argenx policies and procedures • Ensure timely and informative scientific/medical exchanges with external stakeholders that accurately reflect scientific data and research objectives • Deliver high quality scientific/medical education in a variety of settings, including related to disease states of interest, clinical studies, investigational products, licensed products and obtain valuable insights that can be disseminated throughout the organization • Identify potential high-impact medical research projects and publication opportunities, in line with argenx identified areas of interest • Ensure all external interactions are conducted in accordance with argenx objectives, compliance policies and procedures as well as with established legal and ethical standards
• This role will be responsible for identifying, evaluating, and cultivating a network of high-impact external partners that align with our DT strategic objectives. • This position will define and implement engagement models that drive co-creation and deliver sustained, mutual value, translating the company's strategic needs into tangible partnership opportunities. • By building and managing a robust portfolio of alliances, the role will accelerate innovation across Digital Technology (DT) and the broader organization, ensuring we remain at the forefront of technological advancement to better serve patients. • Develop and execute a comprehensive strategy for identifying and scouting high-impact external partners by leveraging market outreach and fostering existing organizational relationships. • Design and formalize clear, structured engagement models and compelling value propositions to ensure the creation of mutually beneficial and sustained partnerships. • Act as the primary bridge between external innovators and internal Digital Technology (DT) teams, ensuring partner capabilities are effectively integrated with the organization's strategic goals. • Oversee the entire lifecycle of strategic alliances, monitoring the health, performance, and value realization of key partnerships to ensure long-term success. • Collaborate with domain leaders to understand their strategic challenges and proactively identify external technologies or partners that can provide solutions and accelerate impact. • Establish and manage a governance framework for partner evaluation, selection, and performance management to maintain a high-quality, strategic ecosystem. • Serve as a central point of expertise on the external innovation landscape, providing insights and recommendations to senior leadership on emerging trends and opportunities. • Champion the value of strategic partnerships across the organization, communicating successes and fostering an environment where external collaboration is seen as a key enabler of growth.
Associate Director, Ethics & Compliance – Risk Assessment and Monitoring
argenxUnited in our commitment to improve the lives of patients
• 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
Device Expert Director, Technical Operations
argenxUnited in our commitment to improve the lives of patients
Role Description Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. Purpose of the Role: To lead and coordinate combination product-related activities across functional teams and projects, ensuring robust design, development, and usability of drug delivery systems, with a strong emphasis on human factors integration and regulatory readiness. Key: bring everything together. Roles and Responsibilities - Cross-Functional Coordination - 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 - Lead regular device team meetings and ensure transparent communication of project status, risks, and milestones - Device Development & Lifecycle Management - Oversee design, industrialization, and lifecycle management of combination products including prefilled syringes and auto-injectors - Drive design control activities including design input/output, verification, validation, and risk management - Human Factors Leadership - Coordinate formative and summative human factors studies in collaboration with internal teams and external providers - Ensure integration of usability engineering into design and risk management processes - Review and interpret human factors data to inform design decisions and regulatory submissions - Regulatory & Quality Interface - Contribute to regulatory submissions including authoring and reviewing device sections - Ensure compliance with applicable standards (ISO 13485, ISO 14971, EU MDR, 21 CFR Part 820) - External Partner Management - Establish and maintain strong relationships with device manufacturers, usability consultants, and packaging suppliers - Lead contracting and oversight of service providers for device-related activities Qualifications - Master degree and 15+ years of relevant experience - Proven track record in medical device development, project management, and cross-functional leadership - Deep understanding of human factors engineering and its application in combination product development - Familiarity with global regulatory frameworks for medical devices and combination products - Strong leadership - Strong interpersonal and communication skills; ability to energize and align diverse teams - Experience with autoinjector platforms (e.g., YpsoMate) is a plus - 25% travel Requirements - Annual base salary hiring range for this position is $188,000.00 - $258,500.00 USD - This job is eligible to participate in our short-term and long-term incentive programs - Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits Company Description At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.
Medical Science Liaison, Multi-Specialty
argenxUnited in our commitment to improve the lives of patients
Role Description Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. The Medical Science Liaison (MSL), a field-based extension of the Medical Affairs team, is an expert on argenx’s scientific data, products, and trials, and is responsible for engagement with Key Opinion Leaders at academic and community centers, including potential and confirmed clinical research sites. The MSL will represent and reflect argenx’s values as a science-driven, patient-centric organization developing innovative medicines for patients and always upholding the highest ethical standards. The MSL will support KOL development and advocacy while serving as a strategic field partner with cross-functional colleagues. The MSL is critical in understanding the management of diseases of interest, mapping the patient journey, identifying unmet medical needs and data gaps, and gathering and sharing insights to enhance patient care. This position is remote and will cover one of the following territories: Northeast, Southeast, North Central, South Central, Northwest, or Southwest. Roles and Responsibilities - Expert medical resource and argenx ambassador. - Develop and continuously maintain the highest scientific and medical expertise of all relevant diseases, products, and development plans. - Identify and develop productive collaborations with Key Opinion Leaders, other important customers, and stakeholders, including professional organizations. - Support the development and implementation of Strategic Territory Plans to advance Medical Affairs strategy. - Maintain a high level of knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of argenx policies and procedures. - Ensure timely and informative scientific/medical exchanges with external stakeholders that accurately reflect scientific data and research objectives. - Deliver high-quality scientific/medical education in various settings, including related to disease states of interest, clinical studies, and investigational products. - Implement Medical Affairs tactics to assess potential new indications, including the treating community, patient pathways, diagnostic practices, and management. - Coordinate the timely and appropriate response to external Medical Information inquiries. - Identify potential high-impact medical research projects and publication opportunities. - Attend appropriate local, national, and international meetings and congresses to gather intelligence and develop productive collaborations. - Ensure all external interactions are conducted in accordance with argenx objectives, compliance policies, and procedures. - Ensure all relevant knowledge, including activities and interactions with important contacts, is systematically captured and disseminated within argenx. Clinical Trial Education and Support - Identify potential investigators and centers for participation in clinical research. - Conduct training with CRO, CRAs, and study site staff as required. - Develop and execute the optimal site contact plan ensuring productive collaborations with sites. - Support the resolution of study issues at a site level. - Provide insightful feedback to internal and external stakeholders as appropriate. Cross-Functional Collaboration - Ensure a close working relationship with all argenx functions, including cross-functional field partners. - Support cross-functional teams to ensure operations are patient-focused. Skills and Competencies - Ability to quickly understand complex disease areas, treatments, and clinical development plans. - Demonstrated ability to build productive collaborations with medical experts. - Excellent communication skills: verbal, written, and when giving presentations. - Able to thrive as part of a team and when working independently. - Proven track record of delivering results that meet or exceed targeted objectives. Education, Experience and Qualifications - Scientific, healthcare or medical degree (PharmD, PhD, MD, DO, DNP, PA). - 2+ years field-based experience in the biopharmaceutical industry. - Experience in clinical R&D and/or medical affairs preferred. - Clinical experience in neurology, hematology, immunology, and/or rare diseases is an advantage. - Knowledge of regulations and practices related to industry interactions with healthcare professionals. - Valid driver’s license. - Must reside within reasonable proximity to a major airport to support required travel. - Ability for 50% travel. Company Description At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates will handle and protect your personal data.
Associate Director Field Based Market Access
argenxUnited in our commitment to improve the lives of patients
Role Description Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. The Field Based Associate Director Market Access Germany is responsible for the development and implementation of German regional market access strategies to secure and optimize reimbursement, pricing and access conditions for argenx product portfolio. The role acts as the key interface between the company and regional stakeholders such as statutory health insurance funds, health authorities, hospital stakeholders, KOLs, and other decision-makers. The Field Based Associate Director Market Access Germany ensures alignment of local implementation with national access strategies, builds trust-based partnerships with key stakeholders, and helps secure sustainable reimbursement and funding pathways in their region. Close collaboration with Commercial and Medical Field Force is essential. Qualifications - A minimum of 10 years of relevant industry experience in biotech/pharma. - 6+ years German Field Based Market Access role experience ideally complemented by SHI and/or KV experience required. - Advanced graduate level training in the natural sciences, medicine, business, engineering, or finance required. - Fluency in German and English. Requirements - Deep understanding of the German healthcare system, especially SHI structure, hospital financing (e.g., DRG, NUB), and outpatient/inpatient access pathways. - Familiarity with AMNOG processes and how national decisions are implemented regionally. - Successful track record in negotiating rebate contracts. - Excellent stakeholder management capabilities and robust external network (KV, SHI, pharmacies etc.). - Strong strategic thinking, negotiation, and communication skills. - Hands-On mentality and willingness to take leadership. - Self-driven, organized, and capable of working autonomously in a field-based setting. - Ability to work collaboratively and effectively together within cross-functional teams and networks. - Demonstrated communication skills, within a multi-cultural and multi-lingual global environment. - Agility and demonstrated adaptability, comfort with ambiguity, trust-building, and resilience. - Derives energy from operating in a dynamic, complex, fast-moving, and frequently changing business environment. - Demonstrable experience with project management, proactive planning, priority setting, and securing alignment. - Drives toward outcomes. - Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop. - Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility. Benefits - Competitive salary with extensive benefits. - Opportunity to grow and be part of a team driven by purpose, creativity, innovation, and science. - This job is eligible to participate in our short-term and long-term incentives program. Company Description argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States, and Japan, we translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.
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