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Principal Pharmacometrician

Job Id R-01288547 Job Type フルタイム Category 臨床開発 Remote フルリモート
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JOB DESCRIPTION

Work Schedule

Standard Office Hours (40/wk)

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.

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 Principal Pharmacometrician position is a "hands-on" position that provides both PK consultation and pharmacokinetic analyses. In addition to leading their own projects, the Principal Pharmacometrician will work with our Clinical Pharmacology team to assist our clients in the design, analysis, and interpretation of PK, PK/PD and population PK studies. The ideal candidates will have the experience, insight and skills necessary to provide interpretation of complex data and will be able to present this interpretation in a format and style that is compatible with client and regulatory requirements.

Discover Impactful Work:

The Principal Pharmacometrician role is responsible for overseeing the design, analysis, interpretation and implementation of modelling and simulation within the clinical pharmacology team.

Keys to Success:

Education

  • Ph.D. or PharmD. in relevant discipline (mathematics, statistics, pharmacokinetics, pharmaceutical sciences, bioengineering, etc), with an emphasis on clinical pharmacokinetics

Experience

  • 5+ years in the Pharmaceutical or CRO Industry
  • Must have experience with pharmacokinetic, medical, pharmaceutical and research concepts
  • Experience required in pharmacokinetic analysis and modeling with strong theoretical background; should have a proven record of accomplishments and publications

Knowledge, Skills, Abilities

  • Must have experience and be proficient as a pharmacokinetic modeler using R and NONMEM software (familiarity with other modelling packages would be advantageous: Phoenix NLME, Simcyp, Gastroplus, Monolix, etc)
  • Strong quantitative skills to develop models with nonlinear behavior, mechanistic or semi-mechanistic components, including must have dose-response modeling experience, QTc analysis, CAR-T analysis, etc.
  • Competent in pharmacokinetic/pharmacodynamic theory
  • Excellent communication skills, both written and oral
  • Ability to guide and manage multiple projects, delivering within required timelines.
  • Self-starter, able to initiate work and motivate others
  • Ability to keep others informed of progress
  • Excellent problem solving capabilities and organizational skills
  • Ability and desire to support, mentor and train others within the team
  • Must have experience creating NONMEM dataset specifications using SDTM and ADaM datasets
  • Strong quantitative skills to develop models with nonlinear behavior, mechanistic or semi-mechanistic components, including must have dose-response modeling experience

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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