About this role
Join Thermo Fisher Scientific as a Senior Pharmacokineticist at the forefront of innovation. Support the top 50 pharmaceutical companies and over 750 biotechs across 2,700 clinical trials in 100+ countries over the last 5 years. Oversee clinical pharmacology and pharmacokinetic aspects of trials from design through analysis and reporting.
Act as lead pharmacokineticist on large or complex projects, designing, analyzing, and interpreting pharmacokinetic, bioavailability, bioequivalence, and pharmacodynamic trials. Review pharmacokinetic and pharmacodynamic results to ensure operational excellence in clinical pharmacology. Manage project activities, timelines, and deliverables with precision.
Serve as senior reviewer on pharmacokinetic projects and mentor Pharmacokineticist and Clinical Pharmacology staff. Participate in team initiatives while working in an office environment with a standard Monday-Friday schedule. Collaborate with senior management on decision-making and process improvements.
Develop and revise department SOPs and guidelines for clinical pharmacology and pharmacokinetic trials. Stay updated on regulatory guidelines and current trends in pharmacokinetics. Assist in staff training, professional development, bid activities, and recruitment efforts.
Requirements
- 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
- 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
- Excellent written and verbal communications skills
Responsibilities
- Serve as Lead Pharmacokineticist or Pharmacokinetic Project Lead on large pharmacokinetic projects and/or development programs
- Manage pharmacokinetic project activities and timelines
- Serve as senior reviewer on pharmacokinetic projects
- Review clinical pharmacology deliverables and documents related to project activities
- Mentor Pharmacokineticist and Clinical Pharmacology staff on project activities
- Assist in staff training and professional development
- Participate in clinical pharmacology initiatives
- Develop and revise department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials
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