Clinical Development Manager
il y a 11 heures
Granada
Clinical Development Manager ¿Le interesa este puesto? Puede encontrar toda la información relevante en la descripción a continuación. Role Overview This role provides operational and scientific support to the Clinical Development team in the planning, execution, analysis, and oversight of preclinical and clinical studies. The position focuses on studies involving pharmacokinetics, toxicology (including toxicokinetics), and analytical validation, ensuring compliance with regulatory requirements, GLP/GCP principles, and internal quality standards. Key Responsibilities Study Planning & Design • Lead the design of preclinical studies and contribute to clinical study design in line with current regulatory requirements for pharmaceuticals and biologics, • Identify, evaluate, and manage external Contract Research Organizations (CROs), ensuring scientific quality, regulatory compliance, adherence to timelines, and budget control, • Oversee study execution at CROs, ensuring protocol compliance and adherence to GLP/GCP standards, • Manage deviations, amendments, and study-related issues, • Review and assess analytical methods and bioanalytical data supporting pharmacokinetic, toxicokinetic, and pharmacology studies, • Calculate and interpret pharmacokinetic parameters, • Contribute to the scientific evaluation of study outcomes, • Maintain accurate, complete, and well-organized study documentation (protocols, contracts, reports, raw data, and correspondence) in line with internal procedures, • Support regulatory activities by preparing or reviewing technical sections of dossiers (e.g., safety, efficacy, pharmacokinetics), • Contribute to expert reports and regulatory submissions, • Stay up to date with relevant regulations, guidelines, and scientific developments, • Contribute to process improvements and provide scientific input to cross-functional teams, • Remote within Europe, the UK, or the US, • Primarily hybrid (home/office-based), with occasional travel for CRO visits, audits, and study-related activities Candidate Profile Education • Degree in Veterinary Medicine, Pharmacy, or a related life science discipline, • Postgraduate training in pharmacology, toxicology, or a related field is highly desirable xcskxlj, • Strong understanding of bioanalysis and pharmacokinetics Experience • Experience within research institutions, universities, CROs, or preferably the pharmaceutical/animal health industry, • Prior involvement in preclinical studies, GLP environments, or pharmacokinetic/toxicology projects is preferred Skills & Competencies • Strong analytical and scientific reasoning skills, • Familiarity with statistical principles, data processing workflows, Excel, and pharmacokinetic modelling tools, • Excellent communication and interpersonal skills with a collaborative, proactive approach, • Ability to manage multiple projects simultaneously while maintaining high-quality documentation, • Strong organizational skills and attention to detail Languages • Fluency in English (spoken and written) is essential, • Additional European languages are considered an advantage
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