Research Scientist II PKPD

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 Win Nonlin® 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.

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