Pharma Clinical development scientist

Major contributor in the assessment of clinical development plan to support the approval of new pharmaceutical products or product LCM (new indication, geo-extension or defense), the Clinical development scientist is responsible of clinical plan implementation including determination and confirmation of the appropriate dosage, evaluation and demonstration of the efficacy of the product but also of its tolerance under field condition. Main Functions: - Clinical Development Strategy: Participate in the development plan for new products or their life cycle management (LCM), including new indications and target species, ensuring alignment with the target product profile and overseeing its implementation. - Clinical Study Management: Conduct and coordinate clinical studies (dose determination, dose confirmation, field studies) in compliance with Good Clinical Practices, international regulatory guidelines (EMA, FDA), and animal welfare standards.Responsibilities include study design, protocol preparation, conduct of the animal phase, result interpretation, and drafting final study reports in collaboration with monitors, data managers, and biostatisticians. - Core Team Role: Serve as a core team member within projects, providing clinical expertise, strategic planning, risk assessment, and support for all clinical activities. - Cross-functional Collaboration: Work constructively and synergistically with other departments (e.g., Innovation, Formulation, Regulatory Affairs, Pre-Clinical, QA). - Regulatory Support: Assist regulatory affairs in preparing the marketing authorization (MA) dossier and responding to questions from regulatory agencies (primarily EMA, but also FDA). - Technical/Marketing Support: Aid the technical and marketing teams in product launches and defenses by preparing scientific abstracts, presentations, and manuscripts for the publication of clinical study data. - Innovation Support: Conduct proof-of-concept studies to support innovation. Expertise Development: Develop specific expertise and a comprehensive understanding of the therapeutic fields relevant to the projects involved. - Network Management: Develop and manage a network of experts. Regulatory and Scientific Monitoring: Ensure continuous monitoring of regulatory and scientific literature. Context and Challenges: The position involves interacting with a large number of stakeholders, managing a diverse range of studies, adhering to stringent regulatory requirements, and operating within an international context (Europe, USA, etc.).