Preclinical PKPD Scientist (FSP)
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as Senior Pharmacokineticist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in clinical pharmacology. As a Senior Sr Pharmacokineticist, you will oversee the clinical pharmacology and pharmacokinetic aspects of clinical trials from design through analysis and reporting. You will act as the lead pharmacokineticist on large or complex projects. Your responsibilities will include designing, analyzing, and interpreting pharmacokinetic, bioavailability, bioequivalence, and pharmacodynamic clinical trials through the analysis, interpretation, and review of pharmacokinetic and pharmacodynamic results.
What You’ll Do:
• Serves as Lead Pharmacokineticist or Pharmacokinetic Project Lead on large pharmacokinetic projects and/or development programs.
• Manages pharmacokinetic project activities and timelines.
• Serves as senior reviewer on pharmacokinetic projects.
• Reviews clinical pharmacology deliverables and documents related to project activities.
• Mentors Pharmacokineticist and Clinical Pharmacology staff on project activities.
• Assists in staff training and professional development.
• Participates in clinical pharmacology initiatives.
• Develops and revises department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.
• Assists senior management team on departmental decision making, bid and marketing activities, recruitment, and process improvement.
• Keeps updates on the regulatory guidelines with respect to pharmacokinetics and related disciplines and current trends.
• Prepare/review
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent combination of education, training, and experience
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
• Strong theoretical background in pharmacokinetics and knowledge of the drug development process
• Knowledgeable of regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of the drug development
• Ability to apply pharmacokinetic theory and concepts using relevant software such as WinNonlin, NONMEM, SAS, S-Plus, R, or other pharmacokinetic packages
• Hands-on experience in performing pharmacokinetics-pharmacodynamics modeling and simulation of clinical trial data is preferred
• Good understanding of statistical methodology required in clinical pharmacology and pharmacokinetic trials
• Proven management skills, as shown through management of multiple projects
• Strong organizational skills across multiple complex projects, managing own and project team work loads, and the ability to adapt and adjust to changing priorities
• Excellent written and verbal communications skills
• Demonstrated initiative and motivation
• Positive attitude, the ability to work well with others, and the ability of effectively mentor junior staff
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, frequent travels both domestic and international.
•Exposure to fluctuating and/or extreme temperatures on rare occasions.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
Apply To This Job
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as Senior Pharmacokineticist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in clinical pharmacology. As a Senior Sr Pharmacokineticist, you will oversee the clinical pharmacology and pharmacokinetic aspects of clinical trials from design through analysis and reporting. You will act as the lead pharmacokineticist on large or complex projects. Your responsibilities will include designing, analyzing, and interpreting pharmacokinetic, bioavailability, bioequivalence, and pharmacodynamic clinical trials through the analysis, interpretation, and review of pharmacokinetic and pharmacodynamic results.
What You’ll Do:
• Serves as Lead Pharmacokineticist or Pharmacokinetic Project Lead on large pharmacokinetic projects and/or development programs.
• Manages pharmacokinetic project activities and timelines.
• Serves as senior reviewer on pharmacokinetic projects.
• Reviews clinical pharmacology deliverables and documents related to project activities.
• Mentors Pharmacokineticist and Clinical Pharmacology staff on project activities.
• Assists in staff training and professional development.
• Participates in clinical pharmacology initiatives.
• Develops and revises department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.
• Assists senior management team on departmental decision making, bid and marketing activities, recruitment, and process improvement.
• Keeps updates on the regulatory guidelines with respect to pharmacokinetics and related disciplines and current trends.
• Prepare/review
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent combination of education, training, and experience
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
• Strong theoretical background in pharmacokinetics and knowledge of the drug development process
• Knowledgeable of regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of the drug development
• Ability to apply pharmacokinetic theory and concepts using relevant software such as WinNonlin, NONMEM, SAS, S-Plus, R, or other pharmacokinetic packages
• Hands-on experience in performing pharmacokinetics-pharmacodynamics modeling and simulation of clinical trial data is preferred
• Good understanding of statistical methodology required in clinical pharmacology and pharmacokinetic trials
• Proven management skills, as shown through management of multiple projects
• Strong organizational skills across multiple complex projects, managing own and project team work loads, and the ability to adapt and adjust to changing priorities
• Excellent written and verbal communications skills
• Demonstrated initiative and motivation
• Positive attitude, the ability to work well with others, and the ability of effectively mentor junior staff
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, frequent travels both domestic and international.
•Exposure to fluctuating and/or extreme temperatures on rare occasions.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
Apply To This Job