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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: Lead Pharmacokineticist
Company: Thermo Fisher Scientific
Location: Office, Standard (Mon-Fri) Schedule

Job Description:
At Thermo Fisher Scientific, we offer meaningful work that makes a global impact. Join our team in advancing science and delivering life-changing therapies that help make the world healthier, cleaner, and safer. We provide our employees with the resources to achieve their career goals while pushing the boundaries of research, development, and clinical trials. Your commitment to quality and precision will play a key role in improving health outcomes for people and communities worldwide.

Location/Division Information:
In the clinical pharmacology division, we provide essential support for understanding pharmacokinetics (PK) and pharmacodynamics (PD) relationships, ensuring the success of drug development efforts. As a Lead Pharmacokineticist, you will oversee pharmacokinetic projects, design clinical trials, and provide strategic input for drug development.

Key Responsibilities:

  • Act as the Lead Pharmacokineticist or Pharmacokinetic Project Lead on projects.
  • Contribute to the design of clinical study protocols from a pharmacokinetic and clinical pharmacology perspective.
  • Analyze and interpret pharmacokinetic data from clinical pharmacology studies.
  • Prepare pharmacokinetic reports and contribute to clinical study reports.
  • Represent the pharmacokinetic project team in cross-functional department activities and client meetings.
  • Manage project timelines and pharmacokinetic activities.
  • Support the development and revision of departmental SOPs for conducting, analyzing, and reporting pharmacokinetic trials.
  • Stay updated on regulatory guidelines and trends in pharmacokinetics and clinical pharmacology.
  • Assist the lead pharmacokineticist on large and complex projects.
  • Contribute to the preparation of regulatory documents for submission.

Knowledge, Skills, and Abilities:

  • Strong theoretical background in pharmacokinetics.
  • Proficiency in pharmacokinetic software such as WinNonlin, NONMEM, SAS, R, or others.
  • Experience in pharmacokinetics-pharmacodynamics modeling and simulation (preferred).
  • Solid understanding of statistical methodology in clinical research.
  • Familiarity with regulatory guidelines for pharmacokinetics in drug development.
  • Proven ability to manage multiple projects.
  • Strong organizational skills and ability to adjust to changing priorities.
  • Excellent written and verbal communication skills.
  • Demonstrated initiative, motivation, and a positive attitude.

Education and Experience:

  • Bachelor’s degree or equivalent in a relevant field.
  • Minimum of 5+ years of relevant experience in pharmacokinetics or a related area, or an equivalent combination of education, training, and experience.

Apply Today:
If you're ready to make a meaningful impact on global health and further your career in clinical pharmacology, apply now.