Dualyx NV (www.dualyx.com), is a Ghent-based biotech company dedicated to the development of novel Treg based therapies to address the needs of patients with difficult-to-treat autoimmune diseases. The company is currently fast-growing and has a pipeline with highly promising immune modulating programs including DT-001, an antibody agonist program targeting the TNF receptor 2 (TNFR2) which is currently in IND-enabling studies. TNFR2 is widely regarded as a master control switch for immunosuppression, making it highly attractive for Treg therapies. Dualyx also has a pipeline of additional Treg programs in early development. Dualyx is backed by a group of well-respected investors including: Fountain Healthcare Partners, Forbion, Andera Partners, V-Bio Ventures, BGV, PMV, VIB, HTGF and GFF.
At the moment, we are looking for a Director Toxicology to strengthen our dynamic research team in Ghent (full-time employment; 40-60% on-site).
The Director Toxicology is responsible for providing leadership, oversight, and management of in vivo safety studies. She/he directs the conduct and quality of all aspects of operations, activities and projects at the site or via CROs. The Director Toxicology designs, implements, manages and maintains all activities in her/his area of responsibilities. She/he must be able to collaborate effectively with a multidisciplinary internal and external team of scientists and specialists in the field of Discovery, Preclinical, Translational and Clinical Development.
Develop toxicology strategies according to regulatory guidelines, provide toxicological expert support to research and development projects
Formulate testing strategies and work plans, review study protocols, monitor studies, interpret testing results and utilize results in product safety assessments
Understand the off target or on target mechanisms of action and in vitro to in vivo translational relevance of models
Plan, coordinate, monitor and report preclinical safety pharmacology and toxicology studies conducted internally or in collaboration with external CROs, including budget and timing
Prepare nonclinical documents as part of regulatory submissions and interactions
Liaise with R&D team to provide it the requested safety/toxicology information. Ensure alignment with internal teams
Proactively demonstrate leadership by advising and sharing knowledge and expert opinions with peers and senior management
Build project timelines and manage the critical path
Translate strategies into operational plans
Develop and analyse scenarios, risk assessment and mitigation planning
Participate in consultant and CRO selection activities
Postgraduate degree (preferably PhD), toxicology training required
At least 5 years of experience as nonclinical toxicologist in a biotechnology, pharmaceutical or CRO setting
Relevant experience in Biopharmaceutical development (protein, monoclonal antibodies) and Immunotoxicology
In-depth knowledge of relevant regulatory guidelines
Agility, rapid response to changes without losing the ability of being organized
Ability to work independently and to collaborate with a group in a goal- and team-oriented setting
Effective communication skills
Fluency in English (written and spoken)
We offer you the unique opportunity to join a high-potential biopharmaceutical company and contribute critically to Dualyx’ development. If you believe your profile fits this job description, please send your application to HR@dualyx.com.