Make your mark for patients To strengthen our Non-Clinical Safety Evaluation group within Early Clinical Development and Translational Science , we are looking for a talented individual for the role of Non-Clinical Safety Lead , based in Braine L'alleud, Belgium or Slough, UK or Cambridge, MA (USA) . About the role As a Non-clinical Safety Lead, you will provide scientific leadership for non-clinical safety across discovery and development programs. You will shape non-clinical strategies, ensure high-quality execution, and support regulatory interactions from early development through clinical progression and post approval. You will:
- Lead, communicate, and execute non-clinical safety strategies aligned with clinical development goals.
- Develop integrated non-clinical safety plans supporting innovative programs. Ensure timely delivery of high-quality non-clinical data and global regulatory documentation.
- Represent UCB in interactions with regulatory authorities and external partners.
- Provide non-clinical safety expertise to discovery and development projects
- Define, lead, and implement non-clinical safety strategies across programs.
- Partner with clinical teams to ensure robust preclinical data supports clinical trial design.
- Contribute to global regulatory submissions (e.g., IBs, Briefing Books, INDs, NDA/BLAs) and interact with regulatory authorities.
- Oversee the design, review, and interpretation of non-clinical studies.
- Manage non-clinical safety programs, including budgets.
- PhD in Toxicology, Pharmacology, or related discipline (or equivalent MS/DVM with experience).
- 5+ years in non-clinical safety (preferably in pharma or biotech).
- Deep understanding of regulatory processes and regulatory toxicology.
- Experience managing and forecasting non-clinical safety budgets.
- Ability to produce high-quality reports and submission documents with subject matter expert support.
- Accredited or registered toxicologist.
- Experience in gene and cell therapy and/or other novel modalities.
Vacancy posted 1 day ago
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