- Lead non-clinical safety strategies and activities (project flowchart and milestones, risk and opportunities)
- Design non-clinical 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 non-clinical safety data internally and recommend a risk-mitigation strategy
- Contribute to or author high-quality non-clinical safety sections for internal governance and regulatory documentation
- Ad hoc participation in meetings with Health Authorities
- Ensure compliance with regulatory trends and guidelines
- 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.
- 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.
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Non-clinical safety senior project representative - Gif-sur-Yvette, France - Servier
Description
Fondé pour servir la santé, Servier est un groupe pharmaceutique international gouverné par une Fondation, qui aspire à avoir un impact sociétal significatif pour les patients et pour un monde durable. Son modèle unique de gouvernance lui permet de servir pleinement sa vocation avec une vision à long terme : être engagé pour le progrès thérapeutique au bénéfice des patients. Les collaborateurs qui composent le Groupe sont engagés autour de cette vocation commune, source d'inspiration au quotidien. Leader mondial en cardiologie, Servier a pour ambition de devenir un acteur reconnu, focalisé et innovant en oncologie en ciblant des cancers difficiles à traiter. C'est pourquoi le Groupe consacre plus de 50 % de son budget de R&D au développement de thérapies ciblées et innovantes en oncologie. Les neurosciences et les maladies immuno-inflammatoires constituent un futur relais de croissance. Dans ces domaines, Servier se focalise sur un nombre restreint de pathologies spécifiques dans lesquelles une caractérisation précise des patients permet de proposer une réponse thérapeutique ciblée, grâce à la médecine de précision. Pour favoriser l'accès à des soins de qualité pour tous, et à moindre coût, le Groupe propose également une offre de médicaments génériques couvrant la majorité des pathologies, en s'appuyant sur des marques fortes en France, en Europe de l'Est, au Brésil et au Nigeria. Dans tous ces domaines, le Groupe intègre la voix du patient à chaque étape du cycle de vie du médicament. Servier, dont le siège social est basé en France, s'appuie sur une solide implantation géographique dans plus de 150 pays et a réalisé, en 2021, un chiffre d'affaires de 4,7 milliards d'euros.
As a Senior Toxicologist, you will be responsible for non-clinical 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 non-clinical safety expert for the project core team as well as the clinical study and safety subteams.
You will be positioned at the new Paris-Saclay Servier R&D site.
Responsibilities :
Profile :
It is an advantage if you have strong background in animal pathophysiology.
Fluid communication; fluent in spoken and written English
Quel que soit votre domaine d'expertise, votre travail au sein du Groupe Servier contribue à faire avancer le progrès thérapeutique au bénéfice des patients. Vous ferez partie d'équipes reconnues pour leur excellence scientifique et développerez votre plein potentiel dans un environnement professionnel qui vous encourage à vous développer. Des parcours d'intégration sur mesure, des opportunités de mobilité, des formations de qualité, un management responsable, un esprit d'équipe... Tout cela et plus encore dans un lieu de travail axé sur votre bien-être.
Chez Servier, nous sommes engagés dans le progrès thérapeutique au service des besoins des patients. Nous mettons la diversité de nos collaborateurs comme une source de richesse pour l'accomplissement de cette vocation.
