argenx · 10 hours ago
Director Toxicology
Boston, MA
Full-time
Hybrid
Director/Executive
7+ years expargenx is a biotech company focused on transforming immunology and delivering medicines for autoimmune patients. They are seeking a Director of Toxicology with expertise in nonclinical safety testing of large molecule therapeutics to lead and contribute to early development project teams and regulatory submissions.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Advise on and create early nonclinical safety screening strategy 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 PharmToxBA 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
Present and contribute to discussions at senior management forums
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
Provide guidance on how to effectively engage with Health Authorities to receive their feedback in a timely manner
Play an active role in shaping the asset development strategy during internal multidisciplinary project/clinical team meetings
Work with Sourcing and the program manager to oversee the timely commissioning of studies to CROs, and participate in vendor alliance governance meetings when appropriate
Qualification
Required
You hold a Ph.D. or possess equivalent experience in the field
Your academic background includes a degree in toxicology or a related discipline
You have at least 7 years of relevant industry experience, with a solid track record in a similar position
You bring deep expertise in nonclinical safety testing and early-stage development of biotherapeutics
You possess a strong understanding of GLP and ICH regulatory requirements, which is essential for ensuring compliance in your role
You have experience 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
While people management experience is an added bonus, what matters most is your ability to lead from within and inspire those around you
Benefits
Competitive salary package
Broad range of benefits
Possibility of working remotely
Support for relocation and obtaining a work visa
Company
argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.
1001-5000 employees
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 CompanyTotal Funding
$3.75BKey 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
Karen Massey
Chief Operating Officer
Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
Recent News
2026-01-12
GlobeNewswire
2026-01-12
2026-01-12
Company data provided by crunchbase