argenx
Director, US Compliance
Boston, MA, USA · Director
Sponsorship not specified$204k-$281kDetected 27 days ago
Computer VisionComplianceAuditingGMPLeadershipCommunicationCollaborationGxP
About the role
- This range reflects our good faith estimate at the time of posting.
- 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.
Responsibilities
- Partner with key business stakeholders to provide guidance and advice regarding compliance obligations, relevant regulations, and areas of potential business opportunity.
- Draft and implement appropriate policies, in collaboration with the Head of US Compliance, legal and other compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in the US (excluding cGMP, cGCP and other GxP guidelines)
- Support routine and risk-based monitoring and auditing of relevant US business activities and related policies and procedures; assist in and oversee the implementation of corrective action plans as necessary; and generate and deliver reports to leadership on monitoring, auditing and risk assessment
- Support onboarding and cross training of other US Compliance team members
- Support content development, presentation delivery and training for the US Compliance Committee
- 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.
- The Director of US Compliance is a key member of our Compliance team who will support our US Compliance program and be based in Boston, MA.
- This individual will help support the Head of US Compliance to further develop a best-in-class compliance program in the U.S. This dynamic team is poised for growth, with cross-functional work with teams in Europe and Asia.
- The Director of US Compliance will support the effort to develop policies and other written standards, develop training materials, execute auditing and monitoring activities, and manage other general compliance activities, including fostering the strong ethical culture of argenx.
Requirements
- A minimum of 5-8 years of biopharmaceutical industry experience in a relevant compliance function, with extensive experience within a commercial stage pharmaceutical or biotech company
- 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.
- Conduct or assist in compliance-related investigations and other allegations of misconduct, as required
- BA/BS required. Experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential
- Expertise in the areas of US corporate commercial healthcare law and regulation, including with respect to 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 pharmaceutical products
- Expertise in the PhRMA Code on Interactions with Healthcare Professionals and other relevant industry codes and guidelines
- Travel 15-20%
- Seeking candidates local to MA
Skills
- Team-player, able to work well with others and communicate with cross-functional colleagues
- Solid understanding of business goals and legal, compliance and regulatory landscape in the US
- High degree of personal, professional and corporate ethics, integrity and responsibility
Compensation
- The annual base salary hiring range for this position is $204,000.00 - $280,500.00 USD.
Benefits
- Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity.
- 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.
- Support the US commercial and medical teams to provide compliance-based input and direction across product portfolio
- Education, Experience and
Company info
- 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.
Equal opportunity
- 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.
This listing is sourced directly from argenx's careers page and normalized into a canonical job model.