Pharmacokinetic Analyst – Clinical Data focus, Remote Possible

🏢 Labcorp📍 Birmingham, AL, United States💼 Full-Time💻 Remote🏭 Pharmaceutical & Biotechnology💰 70000-110000 per year

About the Company

LabCorp (Laboratory Corporation of America Holdings) is a leading global life sciences company that provides comprehensive clinical laboratory services, end-to-end drug development support, and technology-enabled solutions to improve health and improve lives. With a mission to deliver world-class science and solutions, LabCorp is at the forefront of medical diagnostics and pharmaceutical research, offering critical insights to patients, physicians, hospitals, and pharmaceutical companies worldwide.

Job Description

We are seeking a highly motivated and detail-oriented Pharmacokinetic Analyst with a strong focus on clinical data to join our dynamic team. This role is crucial for analyzing pharmacokinetic (PK) and pharmacodynamic (PD) data from clinical trials, contributing to drug development programs across various therapeutic areas. The successful candidate will be responsible for data processing, analysis, interpretation, and reporting of PK/PD results, working closely with clinical pharmacology, biostatistics, and medical writing teams. This is a 100% remote position, offering flexibility while maintaining high standards of collaboration and productivity.

Key Responsibilities

  • Perform non-compartmental and compartmental pharmacokinetic analysis using specialized software (e.g., WinNonlin, Phoenix NLME).
  • Process, validate, and summarize clinical PK/PD data, ensuring data integrity and accuracy.
  • Develop and execute PK/PD analysis plans in accordance with study protocols and regulatory guidelines.
  • Interpret PK/PD results and provide clear, concise summaries for inclusion in clinical study reports, presentations, and regulatory submissions.
  • Collaborate with clinical pharmacologists, biostatisticians, and other scientific personnel to support clinical development programs.
  • Contribute to the development and improvement of internal PK analysis methodologies and tools.
  • Stay updated on industry best practices, regulatory requirements, and scientific advancements in pharmacokinetic analysis.
  • Participate in cross-functional team meetings and present analysis findings.
  • Ensure compliance with Good Clinical Practice (GCP) and internal Standard Operating Procedures (SOPs).

Required Skills

  • Master's or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Clinical Pharmacology, Biostatistics, or a related quantitative field.
  • Minimum of 2 years of experience in pharmacokinetic analysis within the pharmaceutical, biotech, or contract research organization (CRO) industry.
  • Proficiency with pharmacokinetic analysis software (e.g., Phoenix WinNonlin, NONMEM, R, SAS).
  • Strong understanding of pharmacokinetic principles, concepts, and regulatory guidelines.
  • Experience with clinical trial data handling, cleaning, and quality control.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Ability to work independently and collaboratively in a remote team environment.
  • Strong written and verbal communication skills.

Preferred Qualifications

  • Experience with population PK/PD modeling (e.g., using NONMEM, Monolix).
  • Familiarity with R or SAS programming for data manipulation and statistical analysis.
  • Knowledge of relevant regulatory guidelines (e.g., FDA, EMA) pertaining to PK/PD studies.
  • Experience in writing and reviewing sections of clinical study reports (CSRs) related to PK/PD.

Perks & Benefits

  • Comprehensive health, dental, and vision insurance plans.
  • 401(k) retirement plan with company match.
  • Paid time off, including vacation, sick leave, and holidays.
  • Flexible spending accounts (FSAs) and health savings accounts (HSAs).
  • Life and disability insurance.
  • Employee assistance program (EAP).
  • Professional development and continuing education opportunities.
  • Employee stock purchase program (ESPP).
  • Remote work setup support and resources.

How to Apply

If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:

  • An up-to-date Resume or CV
  • A brief cover letter summarizing your experience and motivation

Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.

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