Job Description
The Principal Pharmacometrician role is responsible for overseeing the design, analysis, interpretation and implementation of modelling and simulation within the clinical pharmacology team.
Clinical pharmacology provides the support necessary 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 managing his or her 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.
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Qualifications - External
Education and Experience:
- Ph.D. or PharmD. in relevant discipline (mathematics, statistics, pharmacokinetics, pharmaceutical sciences, bioengineering, etc), with an emphasis on clinical pharmacokinetics
- 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 and 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!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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