About the Company
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to accelerating innovation, driving healthcare forward, and improving patient outcomes worldwide. Our team leverages unparalleled data, expertise, and technology to help clients make more informed decisions and achieve better results.
Job Description
We are seeking a highly motivated and skilled Pharmacokinetic Analyst to join our dynamic team. In this role, you will be instrumental in the analysis and interpretation of pharmacokinetic (PK) data from clinical trials, with a strong focus on utilizing and understanding clinical data sets. This position requires a deep understanding of PK principles, regulatory guidelines, and the ability to apply advanced analytical techniques. As a Pharmacokinetic Analyst, you will contribute significantly to drug development programs by providing critical insights into drug absorption, distribution, metabolism, and excretion.
Key Responsibilities
- Design and execute pharmacokinetic analysis plans for clinical studies across various therapeutic areas.
- Perform non-compartmental (NCA) and population PK analyses using industry-standard software (e.g., NONMEM, Phoenix WinNonlin).
- Interpret and critically evaluate PK results, identifying trends and generating robust conclusions relevant to drug development.
- Collaborate closely with clinical pharmacologists, biostatisticians, data managers, and medical writing teams.
- Prepare comprehensive PK reports, summaries, and presentations for internal review and regulatory submissions.
- Ensure all analyses comply with applicable regulatory guidelines (e.g., FDA, EMA) and company standard operating procedures.
- Contribute to the development and improvement of PK analysis methodologies and tools.
- Participate in scientific discussions and present findings at internal and external meetings.
Required Skills
- Master's or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, or a related quantitative field.
- Minimum of 3 years of experience in pharmacokinetic analysis within the pharmaceutical or CRO industry.
- Proficiency in pharmacokinetic software such as Phoenix WinNonlin, R, or SAS.
- Solid understanding of clinical trial design, data structures, and regulatory requirements.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to convey complex scientific concepts clearly.
- Ability to work independently and as part of a multi-disciplinary team in a fast-paced environment.
Preferred Qualifications
- Experience with population PK modeling (e.g., NONMEM, Monolix).
- Familiarity with TDM (Therapeutic Drug Monitoring) and sparse sampling strategies.
- Knowledge of pharmacometrics and quantitative pharmacology principles.
- Prior experience in regulatory submission support (e.g., IND, NDA, BLA).
- Experience with various therapeutic areas (e.g., Oncology, CNS, Infectious Diseases).
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off (PTO) and holidays.
- Life and disability insurance.
- Flexible spending accounts (FSA) and health savings accounts (HSA).
- Employee assistance program (EAP).
- Opportunities for professional development and continuing education.
- Dynamic and collaborative remote work environment.
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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