Pharma Clinical development scientist

Pharma Clinical Development Scientist

As part of our “Diversity, Equity, and Inclusion” policy, Ceva Animal Health is committed to employing people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Responsibilities

• Major contributor in the assessment of clinical development plan to support approval of new pharmaceutical products or product LCM (new indication, geo‑extension, or defense). Responsible for clinical plan implementation including determination and confirmation of appropriate dosage, evaluation and demonstration of product efficacy and tolerance under field conditions.
• Clinical Development Strategy: Participate in development plan for new products or LCM, ensuring alignment with target product profile and overseeing 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 collaboratively.
• 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 (Innovation, Formulation, Regulatory Affairs, Pre‑Clinical, QA).
• Regulatory Support: Assist regulatory affairs in preparing the marketing authorization dossier and responding to queries from agencies (primarily EMA, also FDA).
• Technical & Marketing Support: Aid technical and marketing teams in product launches and defenses by preparing scientific abstracts, presentations, and manuscripts for publication of clinical study data.
• Innovation Support: Conduct proof‑of‑concept studies to support innovation.
• Expertise Development: Develop specific expertise and comprehensive understanding of therapeutic fields relevant to 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.).

Qualifications

• Veterinary degree or strong scientific knowledge in veterinary fundamentals, especially in internal medicine for pets.
• Minimum 5 years of experience in veterinary research and product development or relevant experience.
• Experience in pet veterinary practices (preferred).
• Extensive knowledge of clinical trial methodology, including Good Clinical Practice, evaluation criteria, biostatistics, clinical trial monitoring, and European regulations.
• Proficiency in clinical project management and study outsourcing, including managing Contract Research Organizations (CROs).
• Familiarity with international regulatory requirements for veterinary product development (EMA, FDA).
• Strong scientific writing skills.
• Excellent communication skills.
• Effective project management abilities.
• Collaborative team spirit.
• Fluency in both spoken and written English (mandatory).
• Proficiency in spoken and written French (preferred).