Research Scientist II PKPD

Description ** 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 health Sciences 3+ years of pharmacokinetic research experience in large and/or small molecule pharmacokinetics in animals and/or humans in pharmaceutical or CRO industry Fluent in English About CTI Advance Your Career We 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 global 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 Impact At 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. Important Note In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( www.ctifacts.com ) or from our verified LinkedIn page. Please Note We will never communicate with you via Microsoft Teams or text message We will never ask for your bank account information at any point during the recruitment process Qualifications Skills Behaviors : Motivations : Education Experience Licenses & Certifications Follow Us on LinkedIn