- You will work transversally with all scientific experts to define specifications and review proposals from external CROs to identify best fit with project requests and DMPK externalization strategy.
- You will ensure that timelines, specifications and quality of work are shared with the CRO contacts, in close link with the scientific experts.
- You will establish clear, consistent, and open collaboration with CROs to ensure optimisation and solutions-oriented approach
- You will organize regular communication with CROs and internal experts to follow up on project progress, help trouble shoot when required and ensure quality of work is consistent with specifications.
- Depending on outsourcing needs, you will perform the scientific coordination and monitoring of the studies performed by external vendors and help troubleshoot issues in collaboration with the scientific expert when required.
- You will be responsible to work closely with internal experts, project stakeholders and CRO to set priotities between studies when required
- You will conduct performance evaluations of external CROs to ensure consistency of the studies subcontracted, define KPis relevant ot the services contracted and monitor them regularly with the CRO contacts.
- You will be responsible for monitoring the budget, and DMPK expenditures in close liaison with procurement, accounts and CROs.
- You will work cross-functionally to contribute to regulatory submissions, and support responses to regulatory agencies through contact with appropriate CROs.
- As part of the continuous improvement role, you will survey litterature and CROs capacities to bring new technologies and industry trends into the portfolio of services available to projects to help improve efficiency and productivity.
- Ph. D. degree (or equivalent experience) in chemistry, pharmacokinetics or other disciplines related to drug discovery and development
- Minimum of 3 to 5 years' experience in the pharmaceutical industry.
- Experience in interacting with external partners and contract research organizations (CROs).
- Good understanding of bioanalysis and pharmacokinetics is a plus
- Experience in multiple drug modalities (ASOs, Protacs, NBEs) is a plus.
- Excellent communication and organizational skills
- Good listening and writing skills in English
- Ability and experience to work collaboratively
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Senior DMPK Externalization Specialist - 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.
We are looking to hire a DMPK Externalization Specialist for a permanent, full-time position at Servier Paris-Saclay R&D Institute, reporting to the Head of Externalization in the global DMPK Department. The remit of the Externalization Team is to provide externalization support and scientific coordination of the outsourced activities of the DMPK department covering all therapeutic entities of Servier portfolio and at all stages of developement from drug discovery to early development and up to life cycle management.
You will be responsible for the identification of potential CROs with required scientific expertise and monitor externalised activities such as in vitro or in vivo studies, non-regulatory or regulatory bioanalytical and metabolism studies and non-clinical pharmacokinetic studies.
Missions:
Profile:
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.
