Senior Safety Medical Evidence & Insights Lead

<p><i>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.</i></p><p></p><p><i>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. </i></p><p></p><p></p><p></p><p>To strengthen our <b>Safety Evidence and Insights</b> team, we are seeking an experienced pharmaceutical industry professional with strong cross‑functional expertise across the full life cycle of product development. In this strategic role, you will connect science to business, translating safety evidence into actionable plans that inform decision‑making and enable differentiated strategies. You should bring experience working in clinical development and/or medical affairs, and patient safety, as you will act as both a thought partner and an executor in a dynamic, evolving environment.</p><p></p><p><b>Preferred locations: Belgium, Switzerland, East Coast US</b></p><p></p><h1><b>PURPOSE OF THE FUNCTION</b></h1><p></p><p>The Senior Safety Evidence Medical Lead will provide strategic medical leadership, tactical oversight and guidance, and practical contribution to various aspects of evidence generation with focus on medical safety of our products and comparisons to available and emerging therapies. This position will collaborate with internal stakeholders across various functions as well as external stakeholders and decision makers to lead the strategy as well as execution of safety evidence generation. The Senior Safety Evidence Lead may act as a medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), treating physicians, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.</p><p></p><p>This role combines medical/scientific expertise, data analytics, and strategic thinking to ensure understanding of safety profile of our products and that of competitors as well as communicating insights to various stakeholders. Active contribution in insight and evidence generating activities is expected.</p><p></p><h1><b>REPORTING LINE</b></h1><ul><li><p>He/she will report to the Head of Safety Evidence and Insights and will closely collaborate with colleagues in Global Patient Safety, Global and Regional Cross Functional Teams from Medical Affairs including RWE, Regulatory, Biostatistics, Clinical Development and others as needed.</p></li></ul><h1></h1><p></p><h1><b>ROLES AND RESPONSIBILITIES</b></h1><ul><li><p>She/he will work closely with other Safety Evidence team members, physicians in Global Patient Safety and well as other internal and external stakeholders and other decision makers to identify evidence gaps, and collaborate on development and execution of Integrated Evidence Generation Plans (IEGPs) in support of argenx innovative therapies <span>including the planning, prioritization, and execution of  real-world studies, with particular  focus on safety aspects and outcomes.</span></p></li><li><p>Monitor the emerging safety profile of our products in comparison to competitor safety profile(s) to understand differentiating aspects, and identify evidence gaps<span> on safety. </span>Utilize analytical methods to interpret safety data from various sources, in order to generate relevant insights.</p></li><li><p>She/he will generate insights to support the safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for the assigned product(s). </p></li><li><p>Acting as a key safety resource for non-safety functions, <span>with respect to evaluation of all factors that may impact safety, all safety endpoints and safety data interpretation on real-world studies and data in order to obtain meaningful outcomes supporting products in development as well as those marketed by argenx. S</span>he/he will analyze safety data from various sources, and effectively communicate key findings to relevant stakeholders. This role involves collaboration across functional areas, presenting safety-relevant information, and engaging with external stakeholders, including key opinion leaders (KOLs).</p></li><li><p>She/he will lead design and protocol development of postmarketing safety studies,  <span>data analyses as well as development of scientific messages and dissemination of data in collaboration with any relevant internal or external stakeholders; </span>serves as internal advisor for safety questions on other RW studies.</p></li><li><p>Collaborate with Scientific Communications on integrated publication plans for safety evidence.</p></li><li><p>Foster an environment of continuous learning/improvement with all internal and external stakeholders. Function as an argenx ambassador for engaging with external stakeholders such as KOLs.</p></li><li><p>Attend relevant internal and external meetings for training, competitor intelligence, and collaboration with KOLs and other experts. </p></li><li><p>Perform other tasks as required to assist in departmental activities.</p></li></ul><p></p><h1><b>SKILLS AND COMPETENCIES</b></h1><ul><li><p>Collaborative with strong communication, interpersonal, and leadership skills and a proven track record of working and communicating effectively within a complex multi-disciplinary environment.</p></li><li><p>Strong active listening skills with ability to incorporate input from a variety of internal and external stakeholders. Communicates routinely and clearly with relevant stakeholders and maintains visibility to meet relevant objectives, strategies and tactics.</p></li><li><p>Drives initiative with ability to work with minimal supervision.</p></li><li><p>Proactive with good organizational skills and “hands on” attitude, reliable and solution oriented.</p></li><li><p>Effective in setting clear priorities among competing activities. Leverages experience and know-how to focus on priority objectives.</p></li><li><p>Highly developed analytical skills to understand complex matrix linkages of safety data from various sources.</p></li><li><p>Demonstrates an ability to manage multiple projects simultaneously and adapt to changing priorities in a fast-paced environment. Skilled in building strong relationships with cross-functional teams and external partners to drive collaborative efforts and achieve common goals.</p></li><li><p>Embraces innovation by constantly seeking new ways to get results in different situations.</p></li></ul><h1></h1><p></p><h1><b>EDUCATION, EXPERIENCE AND QUALIFICATIONS</b></h1><ul><li><p>Medical Degree preferred. PhD, PharmD, or similar degree may be accepted depending on depth of experience.</p></li><li><p>Strong medical/scientific background, inspired by prioritizing patient safety. Experienced in pharmaceutical drug development (clinical development and/or medical affairs) and patient safety.</p></li><li><p>Min 10 years leading scientific / clinical projects or studies within pharmaceutical and/or biotech environment.</p></li><li><p>Good working knowledge of both GCP and GVP.</p></li><li><p>Ability to travel up to 10-20% of time as needed.</p></li></ul><p></p><p></p><p><i>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.</i></p><p></p><p><i>Before you submit your application, CV or any other personal details to us, please review our <a href="http://careers.argenx.com/privacy-policy" target="_blank">argenx Privacy Notice for Job Applicants</a> </i><i>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 </i><a href="mailto:privacy&#64;argenx.com" target="_blank"><i>privacy&#64;argenx.com</i></a><i>.</i></p><div></div><p></p>