
Non-Clinical Safety Lead - Cambridge, MA
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Overview
Job Description
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 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.
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.
Interested? For this role you'll need the following education, experience and skills
- 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:
This position's reasonably anticipated base salary range is $168,000 to $220,500 per year. The actual salary offered will consider internal equity and may also vary depending on the candidate's region, job-related knowledge, skills and experience, among other factors.
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
Unless explicitly stated in the description, this role is hybrid with 40% of your time spent in the office, regardless of your current contractual agreement. If your current working arrangements differ, please contact your Talent Partner to discuss before submitting your application.
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. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID: 92704
Recruiter: John Gasbarre
Hiring Manager: Marie Lemper
Talent Partner: Geraldine Beauduin
Job Level: MM I
Please consult HRAnswers for more information on job levels.
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