Role 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.
The Sr. Pharmacometrician is a hands-on scientific role that provides pharmacometrics consultation and advanced modeling and simulation. In addition to leading assigned projects, the Sr. Pharmacometrician partners with Clinical Pharmacology, Statistics, Programming, and client teams to design, analyze, interpret, and communicate population PK, PK/PD, exposure-response, and related model-informed drug development analyses.
The successful candidate will be able to translate complex quantitative results into clear conclusions and recommendations that are appropriate for client and regulatory audiences.
Qualifications
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Ph.D. or Pharm.D. in a relevant quantitative or biomedical discipline such as pharmacometrics, pharmacokinetics, pharmaceutical sciences, mathematics, statistics, bioengineering, or a related field, with substantial training in clinical pharmacokinetics and pharmacodynamics.
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5+ years of relevant experience in the pharmaceutical, biotechnology, or CRO industry performing pharmacometric modeling and simulation.
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Demonstrated experience in pharmacokinetic and pharmacokinetic/pharmacodynamic analysis and modeling, with a strong theoretical foundation and a record of successful project delivery.
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Scientific publications or conference presentations are preferred.
Requirements
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Required proficiency in NONMEM and R for pharmacometric modeling, simulation, diagnostics, and data analysis.
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Strong theoretical and applied knowledge of population pharmacokinetics, PK/PD, exposure-response, and model-informed drug development.
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Required hands-on experience with dose-response and/or exposure-response modeling; experience translating model results into dose-selection or development decisions is strongly preferred.
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Ability to develop and evaluate nonlinear, mechanistic, semi-mechanistic, and empirical models appropriate to the scientific question.
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Experience with specialized applications such as concentration-QTc modeling, biologics, oncology, cell and gene therapies, or CAR-T programs is advantageous.
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Experience creating and reviewing NONMEM dataset specifications using SDTM and ADaM data structures.
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Working knowledge of pharmacometric model evaluation methods, simulation methodology, uncertainty assessment, and reproducible reporting practices.
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Familiarity with one or more additional quantitative platforms such as Phoenix NLME, Monolix, Simcyp, GastroPlus, SAS, or similar tools is advantageous.
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Strong understanding of clinical pharmacology, pharmacokinetic/pharmacodynamic theory, statistical principles relevant to pharmacometrics, and the drug-development process.
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Knowledge of relevant regulatory guidance and expectations for population PK, exposure-response, dose justification, and model-informed drug development.
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Excellent written and verbal communication skills, including the ability to explain complex quantitative findings to clients, cross-functional teams, and non-specialist audiences.
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Demonstrated ability to lead and manage multiple projects, prioritize competing demands, identify risks early, and deliver high-quality work within required timelines.
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Strong problem-solving, critical-thinking, organizational, and quality-review skills.
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Self-directed and proactive, with the ability to initiate work, keep stakeholders informed, and coordinate the efforts of others when needed.
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Demonstrated ability and interest in mentoring, coaching, and training less-experienced scientists.
Benefits
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Work is performed primarily in an office or remote-office environment with routine use of computer and electrical office equipment.
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Occasional travel may be required for client meetings, internal meetings, conferences, or site visits, including domestic and international travel.
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Long or varied hours may occasionally be required to meet project or client timelines.