Director Toxicology

**Director Toxicology**

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.

**Accountabilities**
- 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

**Qualifications**
- 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)

**Benefits**:

- Life insurance
- Retirement plan

Schedule:

- Monday to Friday

Ability to commute/relocate:

- 9052 Zwijnaarde: Reliably commute or planning to relocate before starting work (required)

Work Location: In person