Toxicologist late stage clinical development and established Assets

argenx SE; Oost-Vlaanderen; Presencial; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Broad range of benefits

Option for remote work

Resumo da oferta

argenx SE is seeking a Toxicologist in Belgium (Zwijnaarde, Ghent) to lead product risk assessments and ensure regulatory compliance for late-stage products. This full-time role involves collaborating with diverse teams and providing expert toxicology advice.

The ideal candidate will have a Ph.D. and at least 5 years of relevant toxicology experience. Strong communication and organizational skills are essential. Remote work options are available, along with a competitive salary and benefits.

Qualificações

• At least 5 years of industry experience in a relevant toxicology position.
• Experience in writing risk assessment reports.
• Board certification (ERT, DABT) is a plus.

Responsabilidades

• Collaborate cross-functionally to drive program success.
• Lead risk assessments during late-stage clinical development.
• Guide and approve toxicological evaluations of E&L profiles.

Conhecimentos

Literature mining

Presentation skills

Communication skills

Organizational skills

Formação académica

Ph.D. in toxicology or related field

Descrição da oferta de emprego

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is building a new kind of biotech company, focusing on science‑based innovation.

The Toxicologist in the PharmTox group will lead product risk assessments for late‑stage and established assets, shaping our approach to safety for programs with established non‑clinical safety programs that expand their global regulatory and marketing footprint.

Key Accountabilities and Responsibilities

• Collaborate cross‑functionally (CMC, regulatory, EHS, external partners) to drive program success and regulatory alignment.
• Lead risk assessments of impurities and extractables/leachables during late‑stage clinical development and for established medicines, ensuring compliance with current regulatory guidelines.
• Support lifecycle of established products including presentation changes and license renewals, serving as the single point of contact across the portfolio.
• Guide and approve toxicological evaluations of E&L profiles for container closure systems, devices, and manufacturing components, applying ICH and EMA/FDA guidelines (PDE, TTC, OEL).
• Interpret in‑silico (Q)SAR analyses and, where appropriate, propose in vitro/in vivo studies with partner experts.
• Develop and maintain best practices, identify resources, gaps and opportunities for improvement, keeping risk assessments up to date with industry trends and regulatory requirements.
• Support regulatory processes for mature products (geographic expansions and license maintenance) and provide expert toxicology advice to the regulatory teams.
• Assist in medical writing during licensing authoring and review non‑clinical sections of regulatory documents.
• Oversee periodic safety reporting of assigned projects and biological safety risk assessments of medical devices.
• Lead the team in answering questions from Health Authorities during geographic expansion and coach junior colleagues.
• Build and maintain productive relationships with external partners and global sourcing.

Primary Areas of Focus

• Risk assessment of potential impurities of argenx products.
• Integrated toxicological risk assessments linked to safety datasheets and EHS.
• Application of risk assessment methodologies (e.g., PDE, TTC, OEL) in line with ICH and EMA/FDA guidelines.
• Compliance with regulatory requirements for mature products and support for geographic expansions.
• Support in the authoring stage of regulatory submissions and periodic safety reporting.

Desired Skills and Experience

• Ph.D. degree or equivalent by experience; degree in toxicology or related field.
• At least 5 years of industry experience in a relevant toxicology position.
• Board certification (ERT, DABT) is a plus.
• Strong literature mining, authoring, and presentation skills.
• Excellent communication; ability to influence stakeholders internally and externally.
• Experience writing risk assessment reports and responding to Health Authority inquiries.
• Self‑directed, servant leadership with strong organizational skills.

Location & Benefits

The position is a full‑time role based in Belgium (Zwijnaarde, Ghent) with the option to work remotely from home. The role offers a competitive salary and a broad range of benefits.

EEO Statement

argenx welcomes all applicants in an inclusive environment and will provide 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.