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 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 position will report directly to the Head of Legal, Americas.
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 Responsibilities:
Provide 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) in generalized Myasthenia Gravis (gMG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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 materials
Serve as a member of argenx Materials Review Committees, along with medical and regulatory colleagues
Provide strategic guidance on interactions with patients, healthcare professionals, institutions, and regulatory agencies
Serve 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 regulations
Work with the business to draft, review and negotiate contracts relating to marketing services, consulting and advisory boards, third party vendors and service agreements
Partner with Compliance to review, revise and provide training on relevant laws, regulatory issues, and argenx policies
Other duties as assigned
Skills and Competencies:
Strong interpersonal and oral and written communication skills; communicates in an open, clear, complete, timely and consistent manner
Able to innovate, analyze and solve problems with supervisory input, anticipating and identifying legal and other business risks and making recommendations to management, as appropriate
Solid understanding of business goals and legal and regulatory landscape
Develop and cultivate collaborative relationships with stakeholders to effectively communicate challenges and opportunities and deliver solutions, as needed
High degree of personal, professional and corporate ethics, integrity and responsibility
Knowledge 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 products
Show flexibility and is open to change in a growing, multi-cultural environment
Able 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 locations
Capable of strategic thinking and proposing innovative solutions to legal- and business-related challenges
A team player, who listens effectively and invites response and discussion
Excellent negotiation skills requiring effective interpersonal communication and oral and written communication skills
Ability to independently manage workload in a fast-paced, results-driven, highly accountable environment
Education, Experience and Qualifications:
Must be based in Boston, MA area OR able to travel to Boston office two days a week
JD from a law school accredited by the American Bar Association (ABA)
Admitted to practice law in one or more states
A minimum of 5 years of relevant legal experience in the biopharmaceutical industry and/or a law firm
Expertise 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 products
The 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
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.
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.
