Associate Director Ethics & Compliance

argenx SE; Town of Belgium (WI); Hybrid; USD 150,000 - 190,000; Full time

Job summary

argenx SE is seeking an Associate Director Ethics & Compliance to lead regional activities across Europe, Australia, and Canada, ensuring compliant commercialization and product launches.

You will develop policies, train staff, audit programs, and partner with Legal and regional teams to foster an ethical culture and robust compliance program.

Requires 4–7 years in regional biotech compliance, fluent English, and a legal degree preferred.

Qualifications

• Regional experience with launching new products and/or new indications, healthcare compliance systems, training employees and transparency.
• Fluent in English; other languages helpful.

Responsibilities

• Advise the business functions on compliance and evolve the Global Ethics & Compliance program regionally.
• Serve as advisor to regional commercial and medical teams for compliant input across product portfolio.
• Review interactions with patients, HCPs, institutions, payors, regulators and other stakeholders.
• Draft policies and guidance in collaboration with Legal and Compliance colleagues to ensure laws are followed.
• Deliver Ethics & Compliance training to the organization, including field staff.

Skills

Regional experience

Communication

Ethics & compliance knowledge

Strategic thinking

Cross-functional collaboration

Education

Legal degree preferred

Biopharma compliance experience

Job 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.

Purpose of the Function The Associate Director Ethics & Compliance is a key member of our globally operating Ethics & Compliance team who will mainly support our commercial and medical operations in the European Region incl. Australia and Canada. This is an opportunity to further develop a best-in-class compliance program by role modelling the business partnership with all functions within argenx. In this role you will be a key advisor across the product life cycle and an enabler of successful product launches and commercialisation at a regional and country level. The responsibilities will include advising on key projects and day to day activities, developing policies or other written standards and training materials incl. providing trainings in the countries, supporting with auditing and performing monitoring activities and other general compliance activities and specifically fostering the strong ethical culture of argenx.

Roles & Responsibilities

• Advise the business functions regarding compliance and continue to evolve the Global Ethics & Compliance program in the region and ensure that it is consistent with the values and principles of the organisation, fit for purpose and complies with applicable legal and regulatory requirements.
• Serving as an advisor to regional and local commercial and medical teams to provide compliance-based input and direction across product portfolio.
• Review and advise on interactions with patients/Patient Organisations, healthcare professionals, institutions, payors, regulatory agencies and other external stakeholders.
• Draft and implement appropriate policies, procedures and guidance, in collaboration with the Head of Ethics & Compliance DM & Germany, Legal and other Ethics & Compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in the respective countries and region (excluding cGMP, cGCP and other GxP guidelines).
• Support adherence to transparency reporting requirements and reporting obligations where required.
• Conduct or assist in compliance-related investigations and other allegations of misconduct, as required.
• Prepare and deliver Ethics & Compliance training and education to the organisation incl. field-based employees to ensure understanding of employee responsibilities and overall Ethics & Compliance framework, as well as related policies and procedures.
• Foster the strong ethical culture of argenx.
• Other duties as assigned.

Skills & Competencies

• Regional experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential.
• Team-player, able to work well with others and communicate with cross-functional colleagues and senior leadership.
• Strong interpersonal and oral and written communication skills; a collaborator who communicates in an open, clear, complete, timely and consistent manner in a multi-cultural and multi-lingual global environment.
• 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.
• Able to innovate, analyse and solve problems with minimal supervisory input, anticipating and identifying Ethics & 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 Europe.
• High degree of personal, professional, and corporate ethics, integrity and responsibility.
• Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop. This includes being comfortable giving and receiving feedback in a diverse environment.
• Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.

Education & Experience

• 4-7 years of regional biopharmaceutical industry experience in a relevant compliance function, with extensive experience within a commercial stage pharmaceutical or biotech company.
• Legal degree preferred, other relevant accreditations or degrees considered.
• Fluent in English; other language skills (Italian, Spanish, French or German) preferred.
• Regional 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 European corporate commercial healthcare law and regulation related to the development and commercialisation of pharmaceutical products.
• Regional Experience in specialty markets, particularly rare diseases, preferred.
• Expertise in the relevant industry codes and guidelines.

Travel

25-30%

Note

Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location. This job is eligible to participate in our short-term and long-term incentives program. The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.

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.

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.

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