Associate Director, US Commercial Counsel (Neurology)

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. Some career opportunities come only once in a lifetime – like a job where you have the extraordinary opportunity to transform patients’ lives. At argenx, these opportunities arise through our unwavering mission to serve patients affected by rare and devastating immunology disorders. We are looking for talented individuals who share this passion and commitment for serving patients to join our dynamic and growing legal team.The US Commercial Counsel is a key member of our global legal, compliance and IP team and is responsible for providing legal, regulatory and healthcare advice in support of the preparations, launch and commercialization of argenx’s in-line products. This position will work closely with the US Commercial and Medical teams and with members of our US and global legal and compliance teams. The position will provide counsel concerning a broad range of legal and regulatory issues, including, among other things: application and interpretation of FDA regulations and guidance, the False Claims Act, Anti-Kickback Statute, HIPAA / privacy law, competition law and other relevant laws and regulations governing the commercialization of biopharmaceutical products, product labeling, promotional and educational activities, marketing strategies, interactions with healthcare professionals, grants, sponsorships, and patient support programs. The candidate will have significant opportunity to expand his or her expertise within a rapidly growing legal department in a global biotech company, with potential responsibilities for litigation, international law roles, and global assignments.Roles and ResponsibilitiesProvide strategic, operational and tactical legal and business insight for the company’s commercialization activities in the US, supporting the ongoing launches of VYVGART (IV) and VYVGART Hytrulo (SC & PFS), with a focus in myasthenia gravis-related indications, in Neurology.Advise clients on the Food, Drug & Cosmetic Act, FDA regulations, the Anti-Kickback Statue, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, speaker bureaus, grants, sponsorships and other programs, communications with FDA, non-promotional materials developed to support scientific exchange and health economics materialsServe as a member of argenx Materials Review Committees, along with medical and regulatory colleaguesProvide strategic guidance on interactions with patients, healthcare professionals, institutions, and regulatory agenciesServe as a subject matter expert in the areas of healthcare law and applicable pharmaceutical marketing, anti-kickback, privacy, fraud and abuse, anti-bribery, and product liability statutes and regulationsWork with the business to draft, review and negotiate contracts relating to market access, marketing services, consulting and advisory boards, third party vendors and service agreementsPartner with Compliance to review, revise and provide training on relevant laws, regulatory issues, and argenx policiesOther duties as assignedSkills and Competencies Strong interpersonal and oral and written communication skills; communicates in an open, clear, complete, timely and consistent mannerAble to innovate, analyze and solve problems with supervisory input, anticipating and identifying legal and other business risks and making recommendations to management, as appropriateSolid understanding of business goals and legal and regulatory landscapeDevelop and cultivate collaborative relationships with stakeholders to effectively communicate challenges and opportunities and deliver solutions, as neededHigh degree of personal, professional and corporate ethics, integrity and responsibilityKnowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, the Food, Drug & Cosmetic Act, FDA regulations and guidance, privacy laws, PhRMA Code on Interactions with Healthcare Professionals, and other applicable laws and regulations relating to the development, sales and marketing of biopharmaceutical productsShow flexibility and is open to change in a growing, multi-cultural environmentAble to work well with others and communicate with cross-functional colleagues and senior leadership; able to establish a working relationship of trust and rapport with colleagues at all levels, both office-based and field-based and across all argenx locationsCapable of strategic thinking and proposing innovative solutions to legal- and business-related challengesA team player, who listens effectively and invites response and discussionExcellent negotiation skills requiring effective interpersonal communication and oral and written communication skillsAbility to independently manage workload in a fast-paced, results-driven, highly accountable environmentEducation, Experience, and Qualifications Must be based in Boston, MA area OR able to travel to Boston office two days a week, on averageJD from a law school accredited by the American Bar Association (ABA)Admitted to practice law in one or more statesA minimum of 5 years of relevant legal experience in the biopharmaceutical industry and/or a law firmExpertise in the areas of commercial healthcare and FDA regulatory law and regulation, including with respect to FDA labeling, promotional matters, healthcare fraud and abuse laws, US transparency laws and regulations, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of biopharmaceutical productsThe preferred candidate will have worked at a leading U.S. national law firm and/or had an in-house counsel position with a leading biotech/pharmaceutical company with significant marketed products#LI-hybrid‎ 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 View email address on click.appcast.io you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at View email address on click.appcast.io. Only inquiries related to an accommodation request will receive a response.SummaryLocation: Boston, MA, USAType: Full time