Toxicology Senior Project Representative

Toxicology Senior Project Representative

Servier

Gif-sur-Yvette, France

As a Senior Toxicologist, you will be responsible for nonclinical safety assessment strategy of new chemical and biological candidates, from preclinical to market authorization. You will drive a project portfolio, working closely with all stakeholders and you will be proactive with regards to clinical development plans, regulation and each molecule’s specificities.

You will be the nonclinical safety expert for the project core team as well as the clinical study and safety subteams.

Responsibilities:

• Lead nonclinical safety strategies and activities (project flowchart and milestones, risk and opportunities);
• Design nonclinical safety studies;
• Provide toxicology and safety pharmacology assessments;
• Ensure a scientific support for business actors in the implementation of safety studies and data analysis, in close interaction with other experts;
• Manage collaborations with the outsourcing management department;
• Share nonclinical safety data internally and recommend a risk-mitigation strategy;
• Contribute to or author high-quality nonclinical safety sections for internal governance and regulatory documentation;
• Ad hoc participation in meetings with Health Authorities;
• Ensure compliance with regulatory trends and guidelines.

Profile:

• You have a Master or a Ph.D. degree in Biology, Human Biology, or another relevant scientific education. ERT, DABT or similar qualification in toxicology and/or safety pharmacology is a plus;
• Five to ten years of experience within non-clinical safety assessment of New Chemical Entities, Oligonucleotides and/or Biologics from the pharmaceutical/biotechnology industry or a CRO. Experience with pre-clinical and clinical stage activities is required;
• It is an advantage if you have strong background in animal pathophysiology;
• You are a person with empowerment, rigor, professionalism, proactivity, reactivity and strong problem-solving skills. You are organized and priority oriented in a portfolio management context. You have got excellent oral and written communication and interpersonal skills. Appetence for internal and external partnership and collaboration are also important;
• Fluid communication; fluent in spoken and written English.