Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Location/Division Specific Information
Clinical pharmacology provides the support vital to elucidate the pharmacokinetics and PK/PD relationships in support of our client's drug development efforts. The Pharmacokinetisit designs pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic clinical trials through analysis and interpretation of pharmacokinetic and pharmacodynamic results. May act as lead pharmacokineticist on projects and participate on large projects with complexity.
Key Responsibilities
- Serves as Lead Pharmacokineticist or Pharmacokinetic Project Lead on pharmacokinetic projects.
- Provides pharmacokinetic and clinical pharmacology input into the design of clinical study protocols.
- Plans, analyzes, and interprets pharmacokinetic data from pharmacokinetic and clinical pharmacology studies.
- Provides pharmacokinetic reports and input into clinical study reports
- Represents pharmacokinetic project team in cross-functional department activities and in client meetings.
- Manages pharmacokinetic project activities and timelines.
- Assists in clinical pharmacology initiatives.
- Assists in development and revision of department SOPs and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.
- Keeps updates on the regulatory guidelines with respect to pharmacokinetics and related disciplines and current trends.
- Supports lead pharmacokineticist on large or complex projects.
- Prepare pharmacokinetic reports and assists with the preparation of regulatory documents for submission.
Knowledge, Skills and Abilities:
- Strong theoretical background in pharmacokinetics
- Ability to apply pharmacokinetic theory and concepts using relevant software such as WinNonlin, NONMEM, SAS, S-Plus, R, or other pharmacokinetic packages
- Knowledge and experience in pharmacokinetics-pharmacodynamics modeling and simulation is preferred
- Good understanding of statistical methodology required in clinical research
- Familiarity with regulatory guidelines relevant to clinical pharmacology and pharmacokinetics areas of the drug development
- Proven management skills, as shown through management of multiple projects
- Good organizational skills with the ability to adapt and adjust to changing priorities
- Excellent written and verbal communications skills
- Demonstrated initiative and motivation
- Positive attitude and the ability to work well with others
Education and Experience:
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 5+ years) or equivalent combination of education, training, and experience