Preclinical Safety Expert (m/f/d)

Job description

Job overview

We are 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. The focus will be mainly on immunomodulatory drugs, covering a range of different modalities.

Responsibilities

·  Serve as Preclinical Safety Project Team Representative on multi-disciplinary teams, with focus on Research and Development projects
·  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
·  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;
·  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, where she/he will provide key contribution 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 

Requirements

·  University Degree  in veterinary medicine or natural science with academic degree (PhD)
·  >10 years of relevant industry experience in early and late stage drug development projects, preferentially in the role as Preclinical Safety Project Team representative
·  Strong record in drug development covering different modalities (antibodies, nucleic acid therapeutics, small molecules, peptides)
·  Excellent scientific background in immunology, immunotoxicology, and/or safety biomarkers
·  In addition strong background in biochemistry, pharmacology, biology, physiology and pathology
·  Investigative mindset and knowledgeable about state of the art technologies in preclinical safety
·  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
·  Excellent communication skills, team spirit and proven ability to collaborate transversally in a global organization
·  Additional qualifications as expert in toxicology would be preferred, but not required

Our offer:

·  An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
·  An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
·  An individual and well-structured introduction and training of new employees.
·  You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
·  As a globally successful and constantly growing company, Sanofi provides international career paths as well.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.