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 large and/or small molecule pharmacokinetics in animals and/or humans in pharmaceutical or CRO industryFluent in EnglishAbout CTIAdvance Your CareerWe invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.Join an Award-Winning Team – Join a integral team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.Make a Lasting ImpactAt CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
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📌 Research Scientist II PKPD (España)
🏢 Cti Clinical Trial And Consulting Services
📍 España