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Research Scientist II PKPD

Role overview

Qualifications

  • 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

Responsibilities

  • 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
  • Analyze, and interpret preclinical and clinical PK studies (DMPK, ADME, BE/BA, Tox, SAD, MAD, etc.)

Key facts

Other skills

  • Quality Control
  • Collaboration
  • Communication
  • Problem Solving
  • Teamwork

About the company

CTI Clinical Trial and Consulting Services logo

CTI Clinical Trial and Consulting Services

Contract Research Organizations (CRO)

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com

Company details

IndustryContract Research Organizations (CRO)
Company size1001 - 5000

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Job 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

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        MR

        Marcus Rivera

        Chief Revenue Officer

        m.rivera@company.com
        linkedin.com/in/marcusrivera
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