Toxicologist Late Stage Clinical Development and Established Assets

Toxicologist Late Stage Clinical Development and Established Assets

argenx

Ghent, Belgium

argenx is looking for a Toxicologist in the PharmTox group to lead product risk assessments of late stage and established assets. The role will be instrumental in shaping our approach to safety for programs that have established nonclinical safety programs and expand their global regulatory and marketing footprint. argenx works with an outsourcing model where scientific and quality oversight from the sponsor is an important part of our work.

Key Accountabilities and Responsibilities:

You will be collaborating cross-functionally to drive program success and regulatory alignment, in a dynamic environment with bold corporate objectives. This is a critical role within our PharmTox team, requiring a strong scientific background and excellent communication skills to collaborate across various capabilities. You will play a key role for the safety assessments of impurities and extractables/leachables throughout late stage clinical development, as well as for established medicines, in compliance with the most current regulatory guidelines. You support the lifecycle of established products including presentation changes and license renewals.

We expect you to be the point of contact for our colleagues in CMC/Technical operations, Regulatory, EHS and outside partners and be the bridge that will collaborate with project toxicologists on response to questions from Health Authorities.

You will lead product risk assessments and work with peers to develop best practices, identify resources, gaps and opportunities. An important part of the role will consist of ensuring that risk assessments remain contemporaneous of industry trends and staying abreast of regulatory requirements.

The ideal candidate will have direct experience in writing risk assessment reports and answer to inquiries from Health authorities. The candidate must be scientifically independent and able to articulate implications and risks from toxicology assessments to a broader audience.

Your primary areas of focus are:

Toxicology risk assessment

• Provide expert scientific advice on risk assessment of potential impurities of argenx products;
• Be the single point of contact for impurity and E&L risk assessments in drug substances and drug products across the entire argenx portfolio;
• Be a single point of contact and support EHS by managing toxicological risk assessments linked to safety datasheets;
• Outsource, guide and approve toxicological evaluations of E&L profiles associated with container closure systems, devices, and manufacturing components;
• Oversee the appropriate application of risk assessment methodologies (e.g. PDE, TTC, OEL) in accordance with ICH and EMA/FDA guidelines;
• Together with our expert partners, interpret in silico (Q)SAR analyses and, where appropriate, propose and evaluate in vitro/in vivo studies;
• Collaborate with cross-functional teams to elaborate compliant and scientifically sound control strategies;
• Develop best practices, identify resources, gaps and opportunities for improvement. Ensure that risk assessments remain contemporaneous of industry trends and regulatory requirements.

Support Regulatory processes for mature product (geographic expansions and license maintenance)

• Be the main partner for colleagues in the regulatory groups and support with expert advice on toxicology aspects of assigned projects;
• Have excellent knowledge of the non-clinical part of the initial dossier of assigned projects and advise on best paths forward. Support medical writing during the authoring stage and be responsible for review of nonclinical parts of regulatory documents for license maintenance, geographic expansion or supplementary submissions;
• Responsible for non-clinical aspects of periodic safety reporting of assigned projects;
• Together with expert partners and CMC, support biological safety risk assessments of medical devices;
• Lead the toxicology team in answering questions from Health Authorities during geographic expansion.

Coaching and leading

• Coach and guide young colleagues in the team;
• Lead network of external partners, together with Global Sourcing, maintain and expand productive relationships.

Desired Skills and Experience:

• Ph.D degree or equivalent by experience;
• Degree in toxicology or equivalent, professional board certification preferred;
• At least 5 years of industry experience in a relevant position;
• Board certification (ERT, DABT) is a plus;
• Lead the argenx way- servant leadership, humble is one of our cultural pillars;
• Effective in organizing self and others, highly structured;
• Strong literature mining and excellent authoring skills of technical and regulatory documents;
• Clear communication, can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills;
• You resonate with the values of argenx and you are ready to drive the Company Culture.