Non-Clinical Safety Lead (Discovery & Development)
UCB · Braine-l'Alleud
Job description
About the role
UCB is seeking a Non-Clinical Safety Lead to provide scientific leadership for non‑clinical safety across discovery and development programs. The role will shape safety strategies, ensure high‑quality data delivery, and support regulatory interactions from early development through post‑approval.
Key responsibilities
- Lead the definition and execution of non‑clinical safety strategies aligned with clinical development goals.
- Develop integrated safety plans for innovative programs and ensure timely delivery of high‑quality data.
- Represent UCB in interactions with regulatory authorities and external partners.
- Partner with clinical teams to ensure preclinical data supports trial design.
- Contribute to global regulatory submissions (IBs, INDs, NDA/BLAs) and prepare briefing documents.
- Oversee design, review, and interpretation of non‑clinical studies.
- Manage non‑clinical safety program budgets and forecasts.
Required profile
- PhD in Toxicology, Pharmacology, or a related discipline (or equivalent MS/DVM with experience).
- Minimum 5 years of experience in non‑clinical safety within pharma or biotech.
- Deep understanding of regulatory processes and regulatory toxicology.
- Experience managing and forecasting safety program budgets.
- Ability to produce high‑quality reports and regulatory submission documents.
Required skills
- Toxicology
- Pharmacology
- Regulatory toxicology
- Gene and cell therapy knowledge
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UCB
Braine-l'Alleud
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