Principal Scientist, Project Toxicologist jobs in United States
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argenx · 1 day ago

Principal Scientist, Project Toxicologist

argenx is a biotech company focused on transforming immunology and delivering medicines for autoimmune patients. The Project Toxicologist will be responsible for developing non-clinical safety strategies and collaborating with multidisciplinary teams to support drug development from early stages to submission.

BiotechnologyClinical TrialsTherapeutics
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H1B Sponsorednote

Responsibilities

Create early nonclinical safety screening strategies including data generation for the selection of relevant species to ensure smooth transition from discovery to IND-enabling studies
Design, development and oversight of nonclinical safety package from IND/CTA through BLA
Obtain buy-in from all stakeholders and ensure alignment with project team goals
Follow up outsourced activities and discuss with experts at the partner companies
Closely work with argenx study monitor and toxicology team on implementation of strategy, including planning, execution and close out of individual studies
Ensure compliant execution of studies by study monitoring either in person or with support of study monitor. Coordinate contributions of other sponsor disciplines (CMC, Bioanalytics, Pharmacokinetics)
Collaborate with other scientific disciplines to interpret the study outcomes and present at internal multidisciplinary project teams
Actively contribute to the development strategy at internal multidisciplinary project/clinical team meetings. Present and discuss work that is under responsibility of the PharmTox team
Collaborate with medical writer and regulatory affairs in development of regulatory dossiers and the investigator brochure while ensuring nonclinical safety -related content is correct and comprehensive
In collaboration with the program manager, ensure correct financial and project planning
Together with Global Sourcing and Alliance Management and program managers, oversee the timely commission of studies to CRO

Qualification

Ph.D. in ToxicologyNonclinical DevelopmentGLPICH ComplianceOutsourced Activities ManagementProject ManagementProactivityInterpersonal SkillsCollaborationFlexibility

Required

You hold a Ph.D. or possess equivalent experience in the field
Your academic background includes a degree in toxicology or equivalent
You have at least 4 years of relevant industry experience, with a solid track record in a similar position
You have a solid understanding of nonclinical development of biotherapeutics
You possess a solid understanding of GLP and ICH regulatory requirements
You have experience in managing outsourced activities and working with external partners
Your interpersonal skills are excellent, and you thrive in a multidisciplinary team environment, collaborating effectively with colleagues from diverse areas
You are proactive, flexible, and well-suited to work in the dynamic, fast-paced environment of a rapidly growing biotech company

Preferred

A professional board certification in toxicology is preferred
You have at least 7 years of relevant industry experience, with a solid track record in a similar position

Benefits

Support for relocation and obtaining a work visa
Possibility of working remotely, combined with part-time on-site presence

Company

argenx

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argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.

H1B Sponsorship

argenx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2023 (5)
2022 (4)
2021 (3)

Funding

Current Stage
Public Company
Total Funding
$3.75B
Key Investors
Forbion Capital Partners
2023-07-18Post Ipo Equity· $1.1B
2022-03-23Post Ipo Equity· $700M
2021-02-02Post Ipo Equity· $999.38M

Leadership Team

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Karen Massey
Chief Operating Officer
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Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
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Company data provided by crunchbase