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 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll 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 Youll 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:
Bachelors 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.