Please submit your application and CV in English

What You'll Do:

Act as principal investigator in the context of GLP studies ensuring compliance
Conduct preclinical and clinical pharmacokinetic (PK) Non-compartmental Analysis (NCA) independently using Phoenix WinNonlin® or other suitable software
Design 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 studies
Contributes to the development of analysis scripts and automation tools
Collaborates in the generation of Data Transfer Agreements and definition of Data Specifications
Analyze, 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 reports
Perform a quality control for pharmacokinetic analysis performed by another scientist according to internal SOPs
Collaborate with limited supervision with 3rd Party CROs / consultants to prepare PK protocols, perform NCA analysis,



reports and supporting documents
Participate in internal meetings, meetings with the sponsor or study teams
Follow and ensure compliance to Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Company Standard Operating Procedures (SOPs), and Sponsor Study protocols, as applicable
Stay abreast of latest PK developments, regulatory guidance (FDA, ICH, EMA), and SOP benchmarks to improve the internal PK practices
Serve on project teams at various stages of discovery and development to support the subject matter expert on the ADME of large and small molecules
Work 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 submissions

What You'll Bring:

Master of Science in Medicine, Pharmacy, Biology, Mathematics, Statistics or other applied

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