Senior Project Toxicologist
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Description
The Senior Project Toxicologist leads non-clinical safety within cross-functional drug development teams, from candidate selection through clinical development. This strategic role shapes safety strategy, establishes company positions for global health-authority interactions and informs external-asset and business development decisions.
- Own non-clinical safety strategy and, under the development project leader, work with cross-functional stakeholders to deliver an integrated development strategy.
- Develop and adapt phase-appropriate non-clinical and regulatory toxicology plans, with clear objectives, decision points, timelines, budgets and risk mitigation aligned with project priorities.
- Design and oversee outsourced toxicology and safety pharmacology studies, ensuring data and reports meet requirements from candidate selection through first-in-human, early efficacy and late-stage clinical development, as applicable.
- Integrate toxicology, safety pharmacology, DMPK, bioanalytical and translational evidence to assess human relevance, target-organ risks and clinical mitigation. Advise project teams, senior management and governance bodies on benefit–risk and development decisions.
- Define and communicate the company’s non-clinical safety positions in global health-authority submissions and interactions, including IBs, DSURs, INDs and scientific advice briefing books.
- Evaluate external assets and in-licensing opportunities, contributing safety assessments to due diligence, asset valuation and deal recommendations.
- Strengthen the preclinical safety function in line with scientific, quality and compliance standards.
- PhD, DVM, PharmD or equivalent advanced degree in toxicology, pharmacology, pathology, biomedical sciences or a related discipline, with required postdoctoral or specialist toxicology training.
- DABT, ERT or equivalent internationally recognised toxicology credential strongly preferred.
- At least 15 years’ progressive experience in pharmaceutical or biotechnology R&D non-clinical safety, regulatory toxicology or integrated safety assessment, including substantial programme- or portfolio-level responsibility.
- Proven non-clinical safety leadership across drug development stages in both clinical-stage biotech and mature pharmaceutical organisations, with the ability to adapt to entrepreneurial and matrixed environments.
- Expert knowledge of FDA, EMA and ICH expectations, GLP and integrated safety assessment; able to translate evolving guidance into proportionate, risk-based plans.
- Proactive, solution-oriented and results-driven, with strong analytical, planning and organisational skills and a collaborative, network-building approach.
- Excellent communication skills and fluency in written and spoken English.
- Leadership competencies: integrates complex evidence into clear, accountable risk-based recommendations; constructively challenges assumptions, aligns stakeholders and influences senior decisions; upholds scientific, strategic, quality and ethical standards, communicates uncertainty transparently and champions safety concerns.
- A high-impact role in an ambitious, innovation-driven biotech company.
- Direct involvement in pioneering therapies for unmet medical needs.
- A collaborative, agile and fast-paced environment.
- A role based in Antwerp, Belgium, with remote-working options tailored to your needs.
- Competitive salary and benefits.