Clinical Development Manager
hace 1 día
Córdoba
pbClinical Development Manager /b /ppbr/ppbRole Overview /b /ppThis 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. /ppbr/ppbKey Responsibilities /b /ppbStudy Planning Design /b /pulliLead the design of preclinical studies and contribute to clinical study design in line with current regulatory requirements for pharmaceuticals and biologics /liliSupport the preparation and review of study protocols, analytical plans, and technical documentation /li /ulpbCRO Management GLP/GCP Oversight /b /pulliIdentify, evaluate, and manage external Contract Research Organizations (CROs), ensuring scientific quality, regulatory compliance, adherence to timelines, and budget control /liliOversee study execution at CROs, ensuring protocol compliance and adherence to GLP/GCP standards /liliManage deviations, amendments, and study-related issues /liliSupport or conduct small-scale internal studies when required /li /ulpbScientific Analytical Support /b /pulliReview and assess analytical methods and bioanalytical data supporting pharmacokinetic, toxicokinetic, and pharmacology studies /liliCalculate and interpret pharmacokinetic parameters /liliContribute to the scientific evaluation of study outcomes /liliEnsure the integrity and consistency of study reports and raw data /li /ulpbDocumentation Regulatory Support /b /pulliMaintain accurate, complete, and well-organized study documentation (protocols, contracts, reports, raw data, and correspondence) in line with internal procedures /liliSupport regulatory activities by preparing or reviewing technical sections of dossiers (e.g., safety, efficacy, pharmacokinetics) /liliContribute to expert reports and regulatory submissions /liliPrepare or review scientific materials, summaries, and publications to support product development and lifecycle management /li /ulpbCompliance Continuous Improvement /b /pulliStay up to date with relevant regulations, guidelines, and scientific developments /liliContribute to process improvements and provide scientific input to cross-functional teams /liliSupport additional activities as required by the Clinical Development team /li /ulpbLocation /b /pulliRemote within Europe, the UK, or the US /liliPrimarily hybrid (home/office-based), with occasional travel for CRO visits, audits, and study-related activities /li /ulpbr/ppbCandidate Profile /b /ppbEducation /b /pulliDegree in Veterinary Medicine, Pharmacy, or a related life science discipline /liliPostgraduate training in pharmacology, toxicology, or a related field is highly desirable /liliStrong understanding of bioanalysis and pharmacokinetics /li /ulpbr/ppbExperience /b /pulliExperience within research institutions, universities, CROs, or preferably the pharmaceutical/animal health industry /liliPrior involvement in preclinical studies, GLP environments, or pharmacokinetic/toxicology projects is preferred /li /ulpbr/ppbSkills Competencies /b /pulliStrong analytical and scientific reasoning skills /liliFamiliarity with statistical principles, data processing workflows, Excel, and pharmacokinetic modelling tools /liliExcellent communication and interpersonal skills with a collaborative, proactive approach /liliAbility to manage multiple projects simultaneously while maintaining high-quality documentation /liliStrong organizational skills and attention to detail /li /ulpbr/ppbLanguages /b /pulliFluency in English (spoken and written) is essential /liliAdditional European languages are considered an advantage /li /ul