argenx

Compensation

Full Description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 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.