Clinical Development Manager
Si sus habilidades, experiencia y cualificaciones coinciden con las de esta descripción del puesto, no demore su solicitud.
Role OverviewThis 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 ResponsibilitiesStudy Planning & DesignLead the design of preclinical studies and contribute to clinical study design in line with current regulatory requirements for pharmaceuticals and biologicsSupport the preparation and review of study protocols, analytical plans, and technical documentationCRO Management & GLP/GCP OversightIdentify, evaluate, and manage external Contract Research Organizations (CROs), ensuring scientific quality, regulatory compliance, adherence to timelines, and budget controlOversee study execution at CROs, ensuring protocol compliance and adherence to GLP/GCP standardsManage deviations, amendments, and study-related issuesSupport or conduct small-scale internal studies when requiredScientific & Analytical SupportReview and assess analytical methods and bioanalytical data supporting pharmacokinetic, toxicokinetic, and pharmacology studiesCalculate and interpret pharmacokinetic parametersContribute to the scientific evaluation of study outcomesEnsure the integrity and consistency of study reports and raw dataDocumentation & Regulatory SupportMaintain accurate, complete, and well-organized study documentation (protocols, contracts, reports, raw data, and correspondence) in line with internal proceduresSupport regulatory activities by preparing or reviewing technical sections of dossiers (e.g., safety, efficacy, pharmacokinetics)Contribute to expert reports and regulatory submissionsPrepare or review scientific materials, summaries, and publications to support product development and lifecycle managementCompliance & Continuous ImprovementStay up to date with relevant regulations, guidelines, and scientific developmentsContribute to process improvements and provide scientific input to cross-functional teamsSupport additional activities as required by the Clinical Development teamLocationRemote within Europe, the UK, or the USPrimarily hybrid (home/office-based), with occasional travel for CRO visits, audits, and study-related activities
Candidate ProfileEducationDegree in Veterinary Medicine, Pharmacy, or a related life science disciplinePostgraduate training in pharmacology, toxicology, or a related xsgfvud field is highly desirableStrong understanding of bioanalysis and pharmacokinetics
ExperienceExperience within research institutions, universities, CROs, or preferably the pharmaceutical/animal health industryPrior involvement in preclinical studies, GLP environments, or pharmacokinetic/toxicology projects is preferred
Skills & CompetenciesStrong analytical and scientific reasoning skillsFamiliarity with statistical principles, data processing workflows, Excel, and pharmacokinetic modelling toolsExcellent communication and interpersonal skills with a collaborative, proactive approachAbility to manage multiple projects simultaneously while maintaining high-quality documentationStrong organizational skills and attention to detail
LanguagesFluency in English (spoken and written) is essentialAdditional European languages are considered an advantage