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Non-Clinical Safety Lead - Cambridge, MA

$168k - $220.5k

UCB Inc.

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. Key responsibilities include: 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 suited for an experienced toxicologist with exposure to gene and cell therapy or other innovative modalities who enjoys working at the interface of science, development strategy, and regulation. What you’ll do 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. 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. Preferred Qualifications Accredited or registered toxicologist. Experience in gene and cell therapy and/or other novel modalities. Salary The base salary range is $168,000 to $220,500 per year, adjusted for internal equity and other factors. Equal Opportunity Employer UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. Reasonable Accommodations Contact View email address on click.appcast.io for assistance with accommodations during the application process. All information provided will be kept confidential. #J-18808-Ljbffr UCB Inc.

Vacancy posted 1 day ago
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