11 open positions available
Lead the design, implementation, and execution of launch readiness plans, collaborate across teams, and manage project timelines to ensure successful product launches. | 3-5 years of experience in launch excellence or product launch within the pharmaceutical or biotech industry, with strong project management and cross-functional collaboration skills. | 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. The Senior Manager, Launch Excellence will support the development and execution of launch readiness projects for argenx. This role involves project planning, launch strategy execution, and vendor and stakeholder management. The ideal candidate will work closely with the launch excellence team, indication teams, and external partners to generate actionable recommendations that help guide the organization’s launch success and overall strategy. This is an exciting time to join an enthusiastic, innovative, and growing team as argenx executes on Vision 2030. We seek a launch leader who thrives in a nimble, fast-paced environment, is willing to embrace the challenge, passionate about science, and deeply motivated by delivering value to people living with rare diseases. Roles and Responsibilities Launch Planning and Execution Lead the design, implementation, and execution of launch readiness plans, including cross-functional launch workshops and scenario planning. Develop tools for launch tracking and performance measurement, including dashboards and scorecards. Collect, organize, and analyze launch data to identify readiness gaps, stakeholder needs, and competitive launch dynamics for relevant indications. Reporting and Presentation Prepare detailed reports and presentations summarizing key launch milestones, risks, and recommendations. Collaborate with the Launch Excellence Team to deliver updates and insights to cross-functional internal stakeholders. Cross-Functional Collaboration Collaborate with cross-functional teams (marketing, medical, analytics, training, market access and field teams) to align launch activities with business strategies and objectives. Lead or participate in cross-functional launch readiness workstream teams to ensure alignment across launch-critical functions. Oversee material management milestones, ensuring timely and compliant delivery of promotional and medical assets. Project Management Manage project timelines, and progress, ensuring that launch deliverables are completed on schedule utilizing project management tools and systems. Maintain a structured filing system for launch documentation, ensuring clarity and accessibility for team members. Develop and maintain standardized dashboards to track performance and compliance metrics. Leverage insights from reporting to drive continuous improvement in launch processes. Organizational Excellence Contribute to an innovative culture that strives for out-of-the-box thinking and creative approaches to launch excellence utilizing best practices and new tools. Seek opportunities to co-create with internal and external stakeholders in efforts to achieve launch excellence. This role is critical to ensuring Launch Excellence continues to drive seamless integration of new technologies. Skills and Competencies Proven experience in product launch readiness and execution. Strong understanding of pharmaceutical compliance and regulatory environments. Excellent project management and cross-functional collaboration skills. Effective verbal and written communication abilities. Ability to manage multiple tasks in project management tools that can be adapted into presentations and key summaries. Strong attention to detail and ability to identify key insights from launch data and activities and ability to thrive in a fast-paced environment. Adaptive and motivated to execute efficiently. Ability to travel up to 15% of the time. Education, Experience, and Qualifications BA or BS, Advanced Degree preferred. 3-5 years of experience in launch excellence, product launch, or project management within the pharmaceutical, biotechnology, healthcare, or related industries. Experience with cross-functional launch planning and execution. Familiarity with leading pharma industry launch tools, vendors, and best practices. For applicants in the United States: The annual base salary hiring range for this position is $128,000.00 - $176,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Develops and manages global legal and compliance policies, designs and implements training programs, and ensures alignment with regulatory standards. | Requires 5+ years in compliance within regulated industries, experience leading policy frameworks and training programs, and strong communication skills. | 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. The Associate Director Global Ethics & Compliance (E&C), Guidance & Training is a key member of our Global E&C team who will support our operations and be based in Boston (US) or Ghent (Belgium). This is an opportunity to further develop a best-in-class global E&C program as a member of a dynamic team poised for growth, with cross-functional work with teams in other regions. We are seeking a visionary leader who is responsible for shaping, maintaining, and advancing argenx’s global Legal, Compliance, Intellectual Property, Privacy and Safety team (LCIP) policy framework and enterprise learning strategy. This role drives policy governance, designs and implements modern compliance education programs, and ensures that policies and training are aligned with applicable standards, and global regulatory expectations and argenx’s Cultural Pillars, Operating Principles and Ways of Working. The role partners closely with leaders in LCIP, and other argenx teams and communities to strengthen organizational understanding of applicable requirements and to embed compliance into everyday decision-making. It requires strategic thinking, exceptional communication skills, and the ability to translate complex requirements into practical, user friendly guidance and training. ROLES AND RESPONSIBILITIES Policy Framework & Governance Lead the development, implementation, and continuous improvement of argenx’s global LCIPpolicies, procedures, and guidance. Ensure policies are clear, practical, risk‑aligned, and globally harmonized while supporting local regulatory requirements and business needs. Manage the full lifecycle of policies (drafting, consultation, governance review, approval, communication, and retirement). Partner with subject matter experts to maintain a cohesive and current policy ecosystem aligned with argenx’s ethical culture and evolving regulatory landscape. Integrate policies and other guidance resources into enterprise‑wide systems, governance processes, and compliance risk management frameworks. Training & Education Develop and maintain argenx’s global LCIP training strategy and curriculum, including role‑based learning paths and an annual training plan. Design and deliver engaging training using varied modalities (e‑learning, workshops, micro‑learning, job aids), guided by adult‑learning principles. Apply technology, digital tools, and AI‑enabled solutions to enhance content quality, relevance, and scalability. Partner with other argenx teams and communities to embed LCIP training into enterprise learning processes and platforms. Ensure regular training for employees, leaders, and key third parties on critical areas. Analytics, Effectiveness & Continuous Improvement Define and track key performance indicators (KPIs) measuring policy adherence, training uptake, and program effectiveness. Translate insights into actionable improvements, incorporating feedback, benchmarking, and industry trends. Stay informed on regulatory changes, LCIP best practices, and innovative training methodologies to keep the program current and future‑fit. Stakeholder Engagement & Communication Collaborate with partners across LCIP, and other argenx teams and communities to identify needs and develop fit‑for‑purpose resources. Ensure consistent and clear messaging across all communications channels (intranet, campaigns, global communications). Represent the Guidance & Training function in internal committees or working groups. Promote a culture of ethics, inclusion, and accountability throughout the organization. Organizational Change Enablement Drive change management initiatives to support adoption of new or revised policies and training programs. Partner with leaders to reinforce expectations, embed compliance into operational processes, and support ongoing cultural evolution. SKILLS AND COMPETENCIES Strong understanding of global compliance expectations, biopharma industry practices, and the strategic role of policies and training within an effective compliance program. Excellent policy drafting and communication skills, with the ability to translate complex requirements into clear, practical guidance for global audiences. Able to envision and implement innovative strategies that transform compliance guidance and training into a strategic, value‑adding capability that enhances business performance and culture Skilled in designing engaging training programs grounded in adult‑learning principles; experience with digital and AI‑enabled learning tools is an advantage. Proficient in using data and analytics to assess program effectiveness and guide improvements. Highly collaborative, with strong facilitation and relationship‑building skills across functions, levels, and cultures. Demonstrated ability to lead change, influence without authority, and drive adoption of new processes and behaviors. Exhibits integrity, sound judgment, discretion, and strong alignment to argenx’s Cultural Pillars. Strong written and verbal communication skills in English; additional languages beneficial. Thrives in a fast‑paced, dynamic, scale‑up biopharma environment; proactive, pragmatic, and solutions‑oriented. Able to manage complexity, balancing strategic thinking with hands‑on execution. Curious, continuously learning, and committed to improving processes and outcomes in a collaborative, inclusive, and patient‑focused culture. EDUCATION, EXPERIENCE AND QUALIFICATIONS Bachelor’s degree required; advanced degree (MS, MA, MBA, JD) or professional compliance certification preferred. 5+ years of experience in compliance within biopharma, biotech, or other highly regulated industries; experience working in multinational environments strongly preferred. Demonstrated success leading policy frameworks, training programs, or other compliance program elements. Prior people leadership experience is highly desirable. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Coordinate media relations, develop advocacy communications, and manage crisis and issues communication strategies for biotech industry initiatives. | Requires 8+ years in corporate communications, experience in biotech or health sciences, and strong media and policy relations skills. | 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. The Associate Director, Media & Patient Communications will operate within a collaborative Corporate Affairs Team to coordinate media relations, patient advocacy communications, public affairs strategies, and issues/crisis communications for the U.S. region (with global coordination). This is a high-visibility role reporting to the Head of Corporate Communications and External Affairs and partnering closely with patient experience, legal, regulatory, commercial, and medical affairs teams. The ideal candidate has experience in life sciences / biotech communications, patient advocacy communications, understands the regulatory and policy landscape, and thrives in high-stakes environments. The person in this role will: Co-create and execute integrated media, patient and advocacy communications, and public affairs strategies that support argenx’ business goals and enhance our reputation Engage in proactive storytelling about product development, scientific insights, patient impact, and advocacy initiatives Serve as a communications partner for planning and response in issues and crisis situations Coordinate and manage media outreach, spokesperson preparation, media training, press releases, Q&A, backgrounders, and briefing materials Monitor media, regulatory, and policy developments, assessing potential business or reputational impact, and leveraging issue trends analyses to develop proactive and reactive communications plans Partner with internal cross-functional teams to align messaging and ensure compliance with legal, regulatory, and medical standards Support U.S. public policy engagement and stakeholder mapping to deliver on the company’s advocacy objectives Co-create and execute crisis communications playbooks, simulations, and readiness drills Coordinate with external agencies and patient advocacy organizations Roles and Responsibilities: Media and Patient Advocacy Communications Strategy Develop and implement media plans to amplify argenx’s scientific story, pipeline milestones, partnerships, and corporate narrative Cultivate relationships with key biotech / health / policy reporters, editors, and media outlets Work closely with patient advocacy medical affairs, regulatory, clinical, legal, commercial, and investor relations teams to ensure message alignment Support product launches, labeling, regulatory filings, and other key business milestones with earned media and stakeholder communications planning Serve as an argenx spokesperson Patient and Patient Advocacy Communications Collaborate with clinical operations and patient advocacy teams to develop and deliver clear, timely updates on clinical trial progress, enrollment, and results to patient and advocacy groups Build and maintain strong relationships with patient advocacy organizations, ensuring open channels for two-way communication and feedback on clinical and non-clinical initiatives Create patient-friendly materials and resources that translate complex scientific and trial information into accessible, actionable content for diverse patient communities Coordinate joint communications efforts with advocacy organizations on awareness campaigns, educational initiatives, and support programs that advance shared goals Issue & Crisis Communications Maintain issue and media monitoring systems, assess reputational risks, flag early warning signs Coordinate development and execution of crisis playbooks, prepare response materials, coordinate across legal and executive stakeholders Conduct scenario planning, media simulations, and training Public Policy & Stakeholder Engagement Monitor U.S. federal, state, and local policy developments relevant to biotech, immunology, rare disease, reimbursement, regulatory oversight, and health access Draft and review messaging for policy engagement Collaborate with external and government affairs communities, as well as with internal and external patient advocacy partners Education, Experience and Qualifications: Required: 8+ years of experience in corporate communications, public affairs, media relations, patient advocacy communications, or similar (ideally in biotech, pharma, health / life sciences) BS/BA Degree Required Demonstrated experience in issues / crisis communications, especially in a regulated environment Demonstrated experience working with advocacy groups, patient groups, and rare disease organizations Familiarity with U.S. health, policy, regulatory, reimbursement and/or legislative environment Excellent writing, editorial, and presentation skills Ability to distill complex scientific / technical information into clear, compelling narratives Strong relationships with U.S. media in biotech / health Experience working with senior executives as spokespeople Comfortable operating in a fast-paced, high-stakes environment Location: Boston, MA or Northeastern United States preferred (Boston, MA; New York, NY; Washington, DC; U.S. based with willingness to travel to Boston / other locations as needed is possible) #LI-Remote This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Develop and implement global regulatory strategies for biotech assets, ensuring successful product development and launch. | Minimum 15 years in regulatory affairs within biopharma, with leadership experience and a strong scientific background. | 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. argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. Our employees are self-disciplined, hardworking, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they are the cornerstone of argenx. For the expansion of our regulatory team, argenx is looking for a Senior Director to support the rapid growth needed for its pipeline. Preferred locations: Belgium, Switzerland, East Coast US Key Accountabilities and Responsibilities: The person in this role is a key member of the global regulatory leadership team and will be working on a late stage asset that is a pipeline in a product and preparing for its first global marketing application. The role provides a critical contribution to the development of product regulatory strategies for different indications and will be a key advisor and enabler of successful product launches and commercialization activities. This role serves as a close business partner and facilitator of regulatory activities across a portfolio of indications, and is expected to contribute to developing sound regulatory strategies globally. This role can be based remotely either near Boston, Belgium or Switzerland. Your primary areas of focus are: Regulatory Strategy for Asset Team Provide strategic, operational and tactical regulatory insight on global activities for assigned programs with focus on innovative ways of addressing barriers to development strategies as well as speeding the availability of our products to patients Work with the rest of the argenx regulatory team, provide strategic regulatory guidance for assigned compound, help guide the organization on the appropriate filing strategy in primary regions, and coordinate across disciplines to ensure timely filings as applicable Articulate global regulatory strategy to Sr. Management Partner across all functions of the asset teams to ensure regulatory input is provided in a timely matter to support business decisions Ensure coordinated regulatory strategy across the regulatory leads on the indication development teams, the asset team and the broader global regulatory team Collaborate with asset teams, IDTs and PMO/Reg PM staff to plan the global submission timeline for the asset and project resourcing requirements and to ensure regulatory strategies are aligned with broader organizational strategies Oversee and mentor the members of the regulatory community Stakeholder Engagement Build and maintain strong relationships with health authorities, external partners, and internal stakeholders to facilitate regulatory approvals. Represent the company in external forums, conferences, or regulatory working groups to stay informed of regulatory updates and share insights. Regulatory Intelligence Collaborate with the regulatory intelligence team and organizationally with Regulatory Policy to continuously assess regulatory requirements and changes in global markets to anticipate challenges and mitigate risks. Desired Skills and Experience: Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on driving and implementing sound regulatory strategies leading to successful submissions and launches. PhD or PharmD preferred. Experience in the development of therapeutics for autoimmune neurology, renal or rheumatology conditions is preferred Prior experience working in rapidly growing pharmaceutical organizations is desirable A thorough understanding and experience with the development and licensure of biologic drugs for orphan and pediatric indications along with knowledge of and monitoring of the evolving landscape of regulations and guidelines Demonstrated ability to coordinate the development of critical regulatory documents involved in the development and approval of medicines with a focus on FDA, EMA, and PMDA A strong scientific background and ability to interact with scientists and clinicians Ability to speak and interact with a diverse group of individuals on technical and business topics Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities, optimizing their effectiveness to enable the timely and quality creation of local submissions A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills Track record of successful interactions with regulatory and health authorities You are a connector, building relationships and partnering across the organization to achieve the company goals You excel in a fast-paced, results-driven, highly accountable environment You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done You show strong leadership with proven ability to build, motivate and develop a team You resonate with the values of argenx and you are ready to drive the Company Culture You combine strategic thinking with the ability to execute, both individually and by leading teams, to achieve operational excellence in the face of challenging goal This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Provide strategic clinical development leadership for neurology-focused autoimmune therapies, overseeing multi-indication programs and collaborating with cross-functional teams. | Requires a Medical Doctor with neurology specialization, 7+ years in pharma/biotech drug development, and proven leadership in clinical programs. | 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. Clinical Development Asset Lead Position purpose Adimanebart (ARGX-119) is a novel anti-MuSK (muscle-specific kinase) agonist monoclonal antibody being developed as a pipeline in a product for neuromuscular diseases. argenx is seeking a dynamic clinical development leader to provide expertise across multiple indications, including CMS (congenital myasthenic syndromes), ALS (amyotrophic lateral sclerosis), and SMA (spinal muscular atrophy) clinical programs, while also driving the rapid evaluation of new indications. The candidate will be responsible for delivering strategic clinical development leadership and oversight as part of the Asset Strategy Team (a cross-functional group focused on maximizing asset potential), working closely with other team members and the indication development teams to maximize the value of the asset and the success of the multi-indication program. The ideal candidate will have significant experience in clinical development for neurologic disorders and a proven track record in drug development. Key Accountabilities/Responsibilities: Deliver strategic clinical development planning and insight for the asset across all stages, including TPP, indication selection, labelling, and assessment of efficacy, safety, and competitor data. Oversee and guide the clinical development physicians, setting standards, coaching, and identifying high performers. Enhance external client satisfaction through strong collaboration with academic medical centers, positioning argenx as a partner of choice and ensuring valuable scientific input. Support internal clients by closely working with senior management and function heads, anticipating needs and ensuring clinical development excellence. Foster cross-functional collaboration on policies and training to streamline procedures and improve efficiency; ensure quality clinical development partnerships. Build and sustain a top-tier clinical development physician team. Desired Skills and Experience: Medical Doctor; neurology specialty education required having acquired in-depth understanding of global drug development , registration and commercialization process based on relevant experience of at least 7 years in the pharma/biotech industry. Excellent English, both written and spoken is a must, as well as ability to travel. Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines). Pro-active problem solver with negotiation skills. Must provide clear vision, direction, and purpose for the different development teams, remaining sensitive to the different cultural needs in a global organisation. Strong communication skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action. Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity, being an accomplished team player whilst maintaining medical integrity. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Drive demand generation and sales objectives in assigned territory through collaboration with healthcare professionals and internal teams. | 5+ years of specialty/rare disease or biologics sales experience, preferably in neurology, proven high sales performance, and willingness to travel extensively. | 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. At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. We are one team, one culture, with one purpose. As part of that team, the Territory Business Manager (TBM) for the Neurology Franchise will drive demand generation through a focused approach on healthcare professionals, academic institutions, and specialty pharmacy/infusion providers. Through exemplary collaboration with internal and field-based partners and a patient-first mindset, the TBM will help deliver on quarterly sales objectives within their assigned geography. TBM’s will report into the Strategic Business Leader. The Territory includes Denver, Colorado (South). Roles And Responsibilities • Travel within assigned geography and occasionally beyond • Territory planning and development of local market strategy • Collaborate with regional colleagues and cross-functional team members • Communicate and engage with assigned HCP’s and affiliated staff • Consistently meet and exceed sales objectives • Effective utilization of market tools and resources • Timely submission of account plans and activity including CRM • Adhere to all argenx compliance policies, guidelines and approved sales messages Skills And Competencies • Ability to sell collaboratively • High level of clinical, product, and business acumen • Problem solving • Working effectively together • Results Oriented • Capable in a virtual sales environment • Demonstrates ownership and accountability • Passionate about serving patients • Understanding of market access dynamics, emphasis on specialty pharmacy and buy & bill accounts Education, Experience And Qualifications • 5+ years of specialty/rare disease/biologics sales experience, neurology strongly preferred • Proven track record of consistent high sales performance • Adept at planning, organizing, and executing sales strategy • Demonstrate ability to collaborate with internal stakeholders • Ability to adapt to an ever-changing environment • Experienced in product launches • Align with core values of the organization – co-creation, humility, excellence, empowerment and innovation • Education: B.S. or B.A. degree preferred 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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.
The Associate Director will oversee the medical review of promotional materials and lead a dedicated indication sub-team within the US Medical Review Community. This role ensures scientific accuracy and fosters collaboration across Medical Affairs, Marketing, Legal, and Regulatory teams. | Candidates must hold a Doctorate degree (PharmD, MD, or PhD) and have over 5 years of experience in the pharmaceutical or biotechnology industry, with at least 3 years in promotional/medical review. Prior experience in Neurology or Rare Disease is preferred. | 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. The Associate Director, US Medical Review will be responsible for overseeing the medical review of promotional materials and leading a dedicated indication sub-team within the US Medical Review Community. This position plays a critical role in ensuring scientific accuracy and cross-functional collaboration across Medical Affairs, Marketing, Legal, and Regulatory teams. The role also serves as the Medical Review lead for co-creation during material development with Marketing and contributes to informed, evidence-based decision-making across the Therapeutic Area ROLES & RESPONSIBILITIES Lead an indication sub-team of Medical Reviewers within the US Medical Review Community, ensuring promotional materials are scientifically accurate, truthful, and compliant with regulatory standards. Provide solutions-oriented feedback and collaborate effectively with cross-functional stakeholders. Represent the Medical Review function in Medical Affairs matrix meetings to support strategic decision-making. Identify and implement process efficiencies within the Medical Review sub-team. Maintain up-to-date scientific knowledge, including product labeling, therapeutic areas, treatment guidelines, publication plans, and competitive landscape. SKILLS AND COMPETENCIES Strong ability to critically evaluate scientific literature and interpret complex data. Excellent written and verbal communication skills tailored to diverse audiences. Proven ability to manage multiple projects, solve problems, and meet deadlines. Effective collaborator in a matrixed environment with a proactive and flexible mindset. Working knowledge of FDA regulations relevant to promotional and medical review. REQUIREMENTS Doctorate degree (PharmD, MD, or PhD). 5+ years of experience in pharmaceutical or biotechnology industry, primarily within Medical Affairs. At least 3 years of direct experience in promotional/medical review. Prior experience in Neurology or Rare Disease preferred. Strong scientific and medical communication skills required. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Provide patient education and support for generalized Myasthenia Gravis patients, coordinate treatment logistics, manage reimbursement issues, and collaborate with internal teams to ensure patient advocacy and compliance. | Current RN license, 5+ years clinical experience including hospital or pharmaceutical settings, 2+ years case management, strong communication and organizational skills, and ability to travel regionally up to 50%. | 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. The Nurse Case Manager (NCM) is the single point of contact for patients and their caregivers. They are aligned regionally and are responsible for educating patients, caregivers and families affected by generalized Myasthenia Gravis (gMG) about the disease and argenx’s products and support services. The NCM may provide resources to help patients better manage their disease and coordinate their treatment. The NCM is responsible for participating in one-on-one communications with patients and their caregivers. Desired Location: Tennessee Roles and Responsibilities: • Provide direct educational training and support to patients and caregivers about gMG and prescribed argenx products • Will manage patient cases across regions as coverage and volume requires • Communicate insurance coverage updates and findings to the patient and/or caregiver • Review and educate the patients and/or caregivers on financial assistance programs that they may be eligible for • Coordinate logistical support for patients to receive therapy and manage their disease • Collaborate with argenx Patient Access Specialist, Case Coordinator, and Field Reimbursement Manager teams to troubleshoot and resolve reimbursement-related issues • Engage with patients and provider case coordinators to ensure appropriate support is being given on an individualized basis • Provide patient-focused education to empower patients to advocate on their behalf • Develop relationships and manage multiple and complex challenges that patient and caregivers are facing • Ensure compliance with relevant industry laws and argenx’s policies • Aligned regional travel will be required for patient education to support patient programs • Must be an excellent communicator and problem-solver • Demonstrated time management skills; planning and prioritization skills; ability to multi-task and maintain prioritization of key projects and deadlines Skills and Competencies: • Demonstrated effective presentation skills; ability to motivate others; excellent interpersonal (written and verbal) skills – with demonstrated effectiveness to work cross-functional and independently • Demonstrated ability to develop, follow and execute plans in an independent environment • Demonstrated ability to effectively build positive relationships both internally & externally • Demonstrated ability to be adaptable to changing work environments and responsibilities • Must be able to thrive in team environment and willing to contribute at all levels with flexibility and a positive attitude • Fully competent in MS Office (Word, Excel, PowerPoint) • Flexibility to work weekends and evenings, as needed • Participate in and complete required pharmacovigilance training • Comply with all relevant industry laws and argenx’s policies • Travel requirements less than 50% of the time Education, Experience and Qualifications: • Current RN License in good standing • Bachelor’s degree preferred • 5+ years of clinical experience in healthcare to include hospital, home health, pharmaceutical or biotech • 2-5+ years of case management • 2+ years of experience in pharmaceutical/biotech industry strongly preferred • Reimbursement experience a plus • Bilingual or multilingual a plus #LI-Remote 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com . 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.
Lead financial operations, vendor management, and strategic projects for the US Medical Affairs & Evidence Generation department, ensuring budget compliance and operational efficiency. | Bachelor’s degree, 3+ years biopharma experience in medical affairs or strategic operations, strong financial acumen, project management skills, and vendor contract expertise. | 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. argenx is a biotechnology company committed to developing innovative treatments for diseases with high unmet needs. This role plays a pivotal part in shaping and evolving the US Medical Affairs & Evidence Generation (USMAEG) Operations while stewarding the department’s budget planning and tracking. The Business Project and Operations (BPO) manager will lead organizational transformation and cross-functional strategic projects, and will own end-to-end financial management: budget planning, forecasting and tracking; vendor contracting and Statement of Work (SOW) development; and procure-to-pay (P2P) activities—including PO and invoice processing and issue resolution—to ensure timely delivery, compliance, and value for USMAEG initiatives. Key Responsibilities Finance & Vendor Operations Lead the annual operating plan (AOP) and ongoing re-forecast cycles for the USMAEG portfolio, including launch scenario modeling and alignment with leadership and Finance. Establish molecule- and indication-level budget trackers; monitor burn rates, identify variances, and drive mitigation actions with Finance. Own monthly/quarterly forecasting and prepare accruals in conjunction with Finance partners. Manage end-to-end P2P for USMAEG internal stakeholders: vendor onboarding, requisitions, PO creation/amendment, and invoice processing to policy and cycle-time targets. Develop, negotiate, and execute SOWs and change orders with vendors; define scope, deliverables, acceptance criteria, and milestone-based payment schedules in partnership with Legal and Procurement. Build dashboards and reports (e.g., Excel, Power BI) that provide real-time visibility into budget consumption, forecast accuracy, and vendor performance. Strategic Project Management & Transformation Design and execute high-impact, cross-functional programs aligned to USMAEG priorities; develop integrated plans, timelines, budgets, and KPIs. Lead change management to drive adoption of new processes and systems; facilitate decision-making routines and executive updates. Identify and implement process improvements and automation that streamline operations and increase data quality and scalability. Coordinate stakeholder and vendor engagement to ensure alignment on objectives, deliverables, risks, and interdependencies. Cross-Functional Collaboration Partner with all functions and teams (HQ & Field) across USMAEG —as well as Finance, Legal, MAEG and Procurement partners—to align plans and enable execution. Facilitate budget-to-milestone linkage with medical value narratives for reviews with leadership and governance bodies. Skills & Competencies Strong financial acumen with experience managing multi-million-dollar operating and project budgets and improving forecast accuracy. Advanced Excel skills and comfort with data visualization (Power BI or similar). Proven strategic project management and planning capability, including KPI design and benefits realization. Contracting and vendor management expertise, including SOW structuring, milestone-based payments, and change control. Excellent communication, collaboration, and stakeholder/vendor management; ability to influence across levels. Detail-oriented with strong organizational skills and proficiency with digital tools/AI to enhance decision-making. Education & Experience Bachelor’s degree in Finance, Accounting, Business, Science, or related field; advanced degree or certifications (CPA, MBA, PMP) preferred. 3+ years of biopharma experience in medical affairs, strategic operations, or business/financial operations. Demonstrated success leading cross-functional initiatives and delivering on-time, on-budget outcomes in a complex, matrixed environment. 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Lead strategic projects and financial operations for US Medical Affairs, including budgeting, forecasting, vendor management, and cross-functional program execution. | Bachelor’s degree with 3+ years biopharma or related strategic operations experience, strong financial acumen, advanced Excel and data visualization skills, and contracting/vendor management expertise. | Description: • Lead organizational transformation and cross-functional strategic projects for US Medical Affairs & Evidence Generation (USMAEG). • Lead the annual operating plan (AOP) and ongoing re-forecast cycles for the USMAEG portfolio, including launch scenario modeling and alignment with leadership and Finance. • Establish molecule- and indication-level budget trackers; monitor burn rates, identify variances, and drive mitigation actions with Finance. • Own monthly/quarterly forecasting and prepare accruals in conjunction with Finance partners. • Manage end-to-end procure-to-pay (P2P) for USMAEG: vendor onboarding, requisitions, PO creation/amendment, and invoice processing to policy and cycle-time targets. • Develop, negotiate, and execute Statements of Work (SOWs) and change orders with vendors; define scope, deliverables, acceptance criteria, and milestone-based payment schedules with Legal and Procurement. • Build dashboards and reports (e.g., Excel, Power BI) providing real-time visibility into budget consumption, forecast accuracy, and vendor performance. • Design and execute cross-functional programs; develop integrated plans, timelines, budgets, and KPIs. • Lead change management to drive adoption of new processes and systems; facilitate decision-making routines and executive updates. • Identify and implement process improvements and automation to streamline operations and increase data quality and scalability. • Coordinate stakeholder and vendor engagement to ensure alignment on objectives, deliverables, risks, and interdependencies. • Partner with all functions and teams (HQ & Field) across USMAEG as well as Finance, Legal, MAEG and Procurement partners to align plans and enable execution. • Facilitate budget-to-milestone linkage with medical value narratives for leadership and governance reviews. Requirements: • Bachelor’s degree in Finance, Accounting, Business, Science, or related field; advanced degree or certifications (CPA, MBA, PMP) preferred. • 3+ years of biopharma experience in medical affairs, strategic operations, or business/financial operations. • Strong financial acumen with experience managing multi-million-dollar operating and project budgets and improving forecast accuracy. • Advanced Excel skills and comfort with data visualization (Power BI or similar). • Proven strategic project management and planning capability, including KPI design and benefits realization. • Contracting and vendor management expertise, including SOW structuring, milestone-based payments, and change control. • Excellent communication, collaboration, and stakeholder/vendor management; ability to influence across levels. • Detail-oriented with strong organizational skills and proficiency with digital tools/AI to enhance decision-making. Benefits:
The Associate Director of Medical Writing will be the primary author of various regulatory documents and will manage medical writers to ensure quality and consistency. This role also involves collaborating with project teams to meet deadlines and maintain inspection-readiness. | Candidates should have a Bachelor's degree in a scientific discipline, with a PhD preferred, and at least 5 years of relevant medical writing experience. Proficiency in American English and familiarity with eCTD writing and regulatory guidelines are essential. | 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. argenx is a clinical-stage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs. For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department. This individual will contribute to and execute the overall strategy for all medical writing processes to according argenx medical writing standards standards and corporate objectives. Roles and Responsibilities: Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience Responsible for inspection-readiness of medical writing activities Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met Responsible for inspection-readiness of medical writing activities Responsible for medical writers assigned to support the medical writing activities for a particular project Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them Capable of working on multiple deliverables simultaneously Desired Skills and Experience: Bachelor’s degree in a scientific or clinical discipline or related field required; PhD preferred Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered Native/bilingual or fluent American English proficiency Solution-focused eCTD Module 5 and Module 2 writing experience for global MAAs Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission Knowledgeable in the regulatory guidances developed for documents authored by medical writing Ability to proofread documents for compliance with internal and external guidance documents Ability to approach issues from various perspectives and accurately summarize data to provide conclusions Ability to work precisely according to procedures and regulations Excellent written and verbal communication skills Ability to prioritize and multi-task successfully in a fast-paced environment Ability to work autonomously, as well as collaboratively in a team Excellent time management skills and a proven ability to work on multiple projects at any given time Must be proficient in MS Office Familiarity with Veeva Vault and Please Review preferred Familiarity with pharmacovigilance documents preferred ** Strong preference for individuals located on the East Coast** #LI-Remote 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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. 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. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.
Create tailored applications specifically for argenx with our AI-powered resume builder
Get Started for Free