Senior Clinical Pharmacologist
il y a 2 semaines
**Date de parution**:25 juin 2025
**Ville**:GIF-SUR-YVETTE
**Pays/Région**:FR
**Type de contrat**:CDI
**N° offre**:9158
Senior Clinical Pharmacologist (H/F)
- Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « engagés pour le progrès thérapeutique au bénéfice des patients ». Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.
Venez vivre et contribuez à faire vivre notre engagement #MovedByYou
- This position is in the Clinical Pharmacology department and potentially covers different therapeutic areas at Servier (Oncology and Neurology). It includes small molecule, monoclonal antibody, and nucleic acid modalities. The individual in this position is part of the therapeutic area project teams from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical development including rapid Proof-of-Concept, as well as experimental medicine studies to evaluate the pharmacology of novel therapeutic approaches. Collaborative interactions with laboratory research scientists, toxicologists, pharmacokinetics experts, modeling and simulation experts, biomarker experts, and late phase therapeutic area clinicians are critical to success in the role. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine plan is essential.
**Main Responsibilities**:
- At the project level, the individual will be a member of the translational medicine group and in specific cases may lead this sub team and participate on the project core team. In these roles, duties include:
- Participates in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
- Reviews, interprets results, and author translational medicine and clinical pharmacology-related clinical documentation, including clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology components of investigator brochures, regulatory documents.
- Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects.
- Coordinates activity of the study team leader for clinical pharmacology studies of assigned project(s).
- Participates in the dose selection for first-in-human studies, Go/No Go decisions when needed.
- Ensures an adequate follow-up of studies and project timelines.
- Communicates project team discussions of interest to the other group members who are involved with the project.
Presents data in appropriate meetings (inside or outside the Group).
**Key stakeholders**:
- Internal: Scientists, clinicians, and project leaders in therapeutic areas, clinical trial managers, data managers, statisticians, representatives from Regulatory Affairs, Non-Clinical Safety, Quantitative Pharmacology and DMPK
- External: investigators, clinical experts, clinical research organizations, health authorities.
**Major Challenges and opportunities**:
- By bringing external expertise to Servier, you will largely contribute to grow a brand-new clinical pharmacology team, and you will leverage your background expertise with strong added value on drug development path.
- Communication of the role of the department; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative attitude.
- Takes an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.
- Ensures Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.
- Ensures high quality documents, requiring strong writing and communication skills.
- Manages aggressive timelines effectively through cross-functional planning.
**Decision Making Authority**:
- Makes front-line decisions on protocol design, execution, dose escalation and safety, information for regulatory authorities
**Profile**:
- Advanced degree: M.D. or M.D./Ph.D., or PharmD or Ph.D degree in a health-related science with at least 5 years of clinical pharmacology experience in biotech or Pharma companies
- Knowledge of drug development
- Broad biomedical knowledge base
- Knowledge and mindset
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