Director Toxicology

Director Toxicology page is loaded## Director Toxicology locations:
Gent, Belgium:
Boston, MA, USAtime type:
Full time posted on:
Posted 30+ Days Agojob requisition :
REQ-3671
* 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.
* The argenx Pharm

ToxBA team is a functional expert group in the Development organization with expertise in nonclinical safety testing, operations of regulated studies and nonclinical and clinical Bioanalytics. We closely work with our colleagues from other functional areas and are part of multidisciplinary teams that are at the heart of argenx discovery and development. argenx works via a strong outsourcing model where scientific and quality oversight from the sponsor is an important part of our work.  

Our working language is English.

Within the Pharm

ToxBA team we are looking for an experienced
** Director,  Toxicology
** with a deep expertise in nonclinical safety testing of large molecule therapeutics. Profound experience with presentation of nonclinical safety data to Health Authorities is a must. The incumbent would be key team member of early development project teams and would be expected to actively contribute to discussions on best practices for creating and executing nonclinical packages to support clinical development strategies.

He/she will present nonclinical safety plans and outcomes to teams and management. argenx works in a network of partnerships and our toxicologists monitor their own studies or they partner with our study monitors to oversee the conduct of GLP studies. He/she will be an important contributor, author and collaborator in submission teams and needs to be able to review regulatory submissions and provide response to regulatory queries.

At argenx, we highly value co-creation and collaboration. Frequent personal interactions are central to our work culture. Project toxicologists can be supported by study monitors and operational specialist for smooth conduct of nonclinical safety studies or they study monitor their own studies, depending on the workload. The project toxicologist is expected to significantly contribute to the authoring and review of regulatory documents and requests for information.

For this role we seek a person who can provide strong leadership and help us further develop our young and motivated team either as a direct people leader or as a coach and advisor.

** This role is based in Ghent, Belgium, and requires on-site presence several days a week. Therefore, candidates must be located in Belgium or be willing to relocate, as remote work from outside Belgium is not an option.*
* ** Along with your CV, we kindly ask that you submit a motivation letter that demonstrates why you're a great fit for this role**.

** 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 Pharm

ToxBA 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…