Director, US Compliance

argenx • Boston, MA

1d • Hybrid

About The Position

argenx is a global immunology company dedicated to transforming immunology and delivering medicines that help autoimmune patients. The company is undergoing multi-dimensional expansion, aiming to reach more patients through its rich pipeline of differentiated assets, including VYVGART, a first-in-class neonatal Fc receptor blocker. argenx is building a new kind of biotech company that maintains its science-based start-up roots while innovating across all business areas, striving to inspire and grow its company, partnerships, science, and people. The Director of US Compliance is a key member of the Compliance team, based in Boston, MA, and will support the Head of US Compliance in further developing a best-in-class compliance program in the U.S. This dynamic team is poised for growth and engages in cross-functional work with teams in Europe and Asia. The role involves supporting the development of policies and other written standards, creating training materials, executing auditing and monitoring activities, and managing other general compliance activities, all while fostering argenx's strong ethical culture.

Requirements

• Strong interpersonal and oral and written communication skills; a collaborator who communicates in an open, clear, complete, timely and consistent manner
• Shows flexibility and is open to change in a growing, multi-cultural environment; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company’s business and culture
• Team-player, able to work well with others and communicate with cross-functional colleagues
• Able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying compliance and other business risks; capable of strategic thinking and proposing innovative solutions to compliance-related challenges
• 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
• Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals
• Comfortable in a results-driven, highly accountable environment where you can make a clear impact; consistently shows initiative, and willing and able to take high levels of responsibility for complex initiatives
• 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
• 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

Responsibilities

• Partner with key business stakeholders to provide guidance and advice regarding compliance obligations, relevant regulations, and areas of potential business opportunity.
• Evolve and align the global compliance program to ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable legal and regulatory requirements
• Support the US commercial and medical teams to provide compliance-based input and direction across product portfolio
• 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
• Conduct or assist in compliance-related investigations and other allegations of misconduct, as required
• Prepare and deliver compliance training and education to the US organization, with particular emphasis on field-based employees, to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
• Support onboarding and cross training of other US Compliance team members
• Support content development, presentation delivery and training for the US Compliance Committee
• Other duties as assigned

Benefits

• short-term and long-term incentive programs
• comprehensive benefits package
• retirement savings plans
• health benefits
• other benefits subject to the terms of the applicable plans and program guidelines

What This Job Offers

• Job Type: Full-time
• Career Level: Director