Toxicologist late stage clinical development and established Assets

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.

argenxis looking for a Toxicologist in thePharmToxgrouptolead product risk assessmentsof late stage and established be instrumental in shaping our approach to safetyfor programs that haveestablishednonclinical safety programsand expand their global regulatory andmarketingfootprint. argenxworks with an outsourcing model where scientific and quality oversight from the sponsor is an important part of our work.

KeyAccountabilitiesandResponsibilities:

You will becollaborating cross-functionally to drive program success and regulatory alignment in is a critical role within ourPharmToxteam requiring a strong scientific background and excellent communication skills to collaborate across variouscapabilities. You will play a key roleforthe safety assessmentsof impurities and extractables/leachablesthroughoutlate stageclinical development as well as for established medicinesincompliancewiththe most current regulatory supportthelifecycle of established products including presentation changesandlicense renewals.

We expect you to be the point of contact for our colleagues inCMC /Technical operations Regulatory EHSand outside partnersandbethe bridgethat will collaborate withproject toxicologistsonresponse to questions from Health Authorities.

Youwillleadproduct risk assessments and work with peers to develop best practices identifyresourcesgapsand important part of therolewill consist ofensuring that risk assessmentsremaincontemporaneous of industrytrends andstayingabreastofregulatory requirements.

The ideal candidate will have direct experience in writingrisk assessmentreportsandanswertoinquiries fromHealth authorities. The candidate must be scientifically independent and able to articulate implications and risks from toxicologyassessments to a broader audience.

Your primary areas of focus are:

Toxicology risk assessment

• Provideexpert scientific advice on risk assessmentof potentialimpuritiesofargenxproducts

• Bethe single point of contact for impurity and E&L risk assessments in drug substances and drug productsacross the entireargenxportfolio

• Be a single point of contact andsupport EHS by managing toxicological risk assessmentslinked tosafety datasheets

• Outsourceguideand approvetoxicological evaluations of E&L profiles associated with container closure systems devices and manufacturing components

• Oversee theappropriateapplicationofrisk assessment methodologies ( TTC OEL)in accordance withICH and EMA/FDA guidelines

• Together with our expert partnersinterpret in silico (Q)SAR analyses and whereappropriate propose and evaluate in vitro/in vivo studies

• Collaborate with cross-functional teams to elaborate compliant and scientifically sound control strategies

• Develop best practicesidentifyresourcesgapsand opportunitiesfor risk assessmentsremaincontemporaneous of industry trends and regulatory requirements

SupportRegulatoryprocesses for mature product (geographic expansions andlicense maintenance)

• Bethe mainpartner for colleagues in the regulatory groups and support with expert advice on toxicology aspectsofassigned projects

• Have excellent knowledge of thenon-clinicalpart of theinitialdossierof assigned projectsandadviseon best medical writing during the authoring stage andbe responsible forreview of nonclinicalpartsofregulatorydocumentsforlicense maintenancegeographicexpansionor supplementary submissions.

• Responsiblefor non-clinical aspectsofperiodic safety reportingof assigned projects

• Together with expert partners and CMC support biological safety risk assessments of medical devices

• Lead the toxicology teamin answering questions from Health Authorities during geographic expansion

Coachingand leading

• Coach andguideyoung colleagues in the team

• Lead network of external partners together with Global Sourcingmaintainand expandproductive relationships.

Desired Skills and Experience:

• or equivalent by experience

• Degree in toxicology or equivalent professional board certification preferred

• At least5years of industry experience in a relevant position

• Board certification (ERT DABT) is a plus

• Lead theargenxway- servantleadershiphumble is one of our cultural pillars.

• Effectivein organizing self and others highly structured

• Strong literature mining andexcellentauthoring skillsof technical and regulatory documents

• Clear communicationcan influence stakeholders effectively both internally and externally with outstanding presentation written and verbal communication skills

• You resonate with the values ofargenxand you are ready to drive theCompany Culture

Offer

• Youll work in a successful and rapidly growing biotech company where we foster a dynamic and supportive work environment.

• This is a full-time position youll be part of a growing team with plenty of opportunities to make an impact.

• We offer a competitive salary package that comes with a broad range of benefits. The level assigned to this position will be determined based on the relevant experience of the final candidate.

• We also provide the possibility of working remotely from your home office in Belgium combined with part-time on-site presence in Zwijnaarde (Ghent) offering you flexibility in your work routine.

Along with your CV we kindly ask that you submit a motivation letter that demonstrates why youre a great fit for this role.

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.

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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