Non-Clinical Safety Lead - Cambridge, MA

UCBCambridge, MA
6d$168,000 - $220,500Hybrid

About The Position

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 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. This role is well suited to an experienced toxicologist—ideally with exposure to gene and cell therapy or other novel modalities—who enjoys working at the interface of science, development strategy, and regulation. You will thrive in an environment where you can share expertise across functions and global UCB sites, engage with cutting-edge science and build collaborative networks to drive cross-functional success.

Requirements

  • 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.

Nice To Haves

  • Accredited or registered toxicologist.
  • Experience in gene and cell therapy and/or other novel modalities.

Responsibilities

  • 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.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Ph.D. or professional degree

Number of Employees

1,001-5,000 employees

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