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10 Dec. 11, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Principal Pharmacometrician
Company: Thermo Fisher Scientific
Location: Not specified
Work Schedule: Other
Environmental Conditions: Office

Job Description:
At Thermo Fisher Scientific, you will engage in meaningful work that has a global impact. Our mission is to help our customers create a healthier, cleaner, and safer world. By joining our team, you will contribute to the advancement of science through research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries, we are committed to improving health outcomes by driving progress in laboratory, digital, and decentralized clinical trial services.

Location/Division Specific Information:
In the Clinical Pharmacology team, we play a pivotal role in supporting drug development through pharmacokinetics (PK) and PK/PD relationships. The Principal Pharmacometrician is a hands-on role that involves both PK consultation and analysis, providing leadership on complex projects and working alongside the Clinical Pharmacology team to assist clients with PK study design, analysis, and interpretation.

Key Responsibilities:

  • Lead the design, analysis, and implementation of pharmacometric modeling and simulation in clinical pharmacology studies.
  • Provide expert consultation and interpretation of pharmacokinetic, PK/PD, and population PK data.
  • Collaborate with clients to ensure that data interpretation aligns with both client and regulatory requirements.
  • Mentor and guide team members, fostering knowledge-sharing and development.
  • Ensure timely delivery of project milestones, managing multiple projects simultaneously.
  • Present complex data in a clear, concise format suitable for both clients and regulatory bodies.
  • Manage and lead projects, ensuring accurate and high-quality outputs.

Education and Experience:

  • Ph.D. or PharmD. in a relevant field (e.g., pharmacokinetics, pharmaceutical sciences, bioengineering, mathematics, or statistics), with a focus on clinical pharmacokinetics.
  • 5+ years of experience in the pharmaceutical or CRO industry.
  • Proven experience in pharmacokinetic analysis and modeling, with a strong theoretical foundation.
  • A history of accomplishments and publications in the field.

Knowledge, Skills, and Abilities:

  • Proficiency in pharmacokinetic modeling using software such as R and NONMEM.
  • Experience with other modeling packages (e.g., Phoenix NLME, Simcyp, Gastroplus, Monolix) is a plus.
  • Strong quantitative skills, including dose-response modeling and QTc analysis.
  • Deep understanding of pharmacokinetic/pharmacodynamic theory.
  • Exceptional written and oral communication skills.
  • Proven ability to manage projects and deliver results within timelines.
  • Strong problem-solving and organizational skills.
  • Ability to mentor, support, and train junior team members.
  • Experience in creating NONMEM dataset specifications using SDTM and ADaM datasets.

Benefits:
We offer competitive remuneration, annual incentive plans, healthcare, and a range of employee benefits. At Thermo Fisher Scientific, you'll work with a forward-thinking organization that values integrity, intensity, involvement, and innovation, offering outstanding career and development opportunities.

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Jobs at Thermo Fisher