Preclinical Safety Expert

Pre-Clinical Safety Expert (f/m/d)

Our position

Sanofi is seeking an experienced toxicologist who is highly motivated to work in global research and development project teams. The successful candidate will provide scientific expertise on toxicology and safety pharmacology needs to the project teams and will be responsible for designing and executing safety strategies. As a toxicologist at Sanofi, you would have the chance to develop your skills and work across various modalities, including Biologics, small molecules, mRNA, cell therapy, and gene therapy.

Additionally, we are open to partial remote working schedules for this role.

About the job:

• Serve as Preclinical Safety project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule compounds for regulatory submissions.

• Responsible for designing and coordinating multi-disciplinary efforts to support projects progression, i.e.:

  • developing the preclinical safety strategy

  • design and interpretation of toxicity studies and safety pharmacology studies

  • conduct of preclinical GLP-safety studies at contract research organizations (CROs) as scientific study monitor

  • review of written safety pharmacology and toxicology reports

  • communication of results to project teams and management

  • authoring of the nonclinical document sections for regulatory documents; (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)

• Close interaction with multiple partners in pre-clinical safety as well as key stakeholders (Pharmacology, DMPK, Chemistry, Regulatory Affairs, Clinical, Project Leaders & Managers, Pharmacovigilance, etc.) on a daily basis is key and requires excellent communication and negotiation skills

• Guide issue-resolution teams, provide key contributions to hypotheses generation and drive the scientific strategy for toxicology issue resolution in drug discovery and development projects.

• · Ensure high scientific standards and adhering to requested timelines in all aspects of the position

• · Participate in local and global Preclinical safety Department activities (staff meeting, scientific forums, etc.), and special projects

About you:

• PhD in toxicology, pharmacology, immunology, veterinary medicine or related disciplines and two years of postdoctoral experience

• > 5 years of relevant industry experience in early and late-stage drug development projects, preferentially in the role as Preclinical Safety Project Team representative

• Excellent scientific background in immunology and/or immunotoxicology

• Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules

• Experience as a GLP Study Director and/or as study monitor for studies at contract research organizations (CROs) would be preferred

• Experienced in the preparation of regulatory documents for submission to health authorities

• Excellent verbal and written communication skills, team spirit and proven ability to collaborate transversally in a global organization

• Investigative mindset and knowledgeable about state-of-the-art technologies in preclinical safety

• Additional qualifications as expert in toxicology would be preferred

Pursue progress, discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!