What You'll Do:Act as principal investigator in the context of GLP studies ensuring complianceConduct preclinical and clinical pharmacokinetic (PK) Non-compartmental Analysis (NCA) independently using Phoenix WinNonlin® or other suitable softwareDesign with limited supervision and optimize PK plan, sampling, and dosing schedules for study protocols and draft Data Analysis Plans, includes animal, healthy volunteer and patient studiesContributes to the development of analysis scripts and automation toolsCollaborates in the generation of Data Transfer Agreements and definition of Data SpecificationsAnalyze, and interpret preclinical and clinical PK studies (DMPK, ADME, BE/BA, Tox, SAD, MAD, etc.)Analyze with limited supervisions output data in order to prepare regulatory level reportsPerform a quality control for pharmacokinetic analysis performed by another scientist according to internal SOPsCollaborate with limited supervision with 3rd Party CROs / consultants to prepare PK protocols, perform NCA analysis, reports and supporting documentsParticipate in internal meetings,



meetings with the sponsor or study teamsFollow and ensure compliance to Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Company Standard Operating Procedures (SOPs), and Sponsor Study protocols, as applicableStay abreast of latest PK developments, regulatory guidance (FDA, ICH, EMA), and SOP benchmarks to improve the internal PK practicesServe on project teams at various stages of discovery and development to support the subject matter expert on the ADME of large and small moleculesWork closely with project teams, line management and other interested third parties to assure high quality and timely delivery of written reports to support Safety Review Committees for dosing decisions and/or regulatory submissionsWhat You'll Bring:Master of Science in Medicine, Pharmacy, Biology, Mathematics, Statistics or other applied health Sciences3+ years of pharmacokinetic research experience in l

📌 Research Scientist II PKPD (España)
🏢 Cti Clinical Trial And Consulting Services
📍 España