About the Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. With a commitment to science and a focus on transforming patients’ lives, BMS is a leader in oncology, immunology, cardiovascular, and fibrosis research. We are dedicated to creating a diverse and inclusive environment where every employee can thrive and contribute to our shared purpose.
Job Description
We are seeking a highly motivated and skilled Pharmacokinetic Analyst with a strong focus on clinical data to join our innovative team. This role is crucial for the analysis and interpretation of pharmacokinetic (PK) data from clinical trials, supporting drug development programs across various therapeutic areas. The successful candidate will contribute to regulatory submissions and the advancement of our robust pipeline. This position offers the flexibility of remote work, allowing you to contribute from anywhere within the United States.
Key Responsibilities
- Perform pharmacokinetic data analysis using industry-standard software (e.g., WinNonlin, R, SAS) for clinical studies.
- Develop and validate PK analysis methods and data sets for use in clinical studies.
- Interpret PK results and prepare comprehensive reports, presentations, and summaries for internal teams, regulatory bodies, and publications.
- Collaborate effectively with clinical pharmacology, biostatistics, and medical writing teams to ensure data integrity, accurate reporting, and timely delivery of study results.
- Contribute to the design of clinical trials from a PK perspective, including sample size calculations and sampling schedules.
- Maintain up-to-date knowledge of regulatory guidelines (e.g., FDA, EMA) and industry best practices in PK/PD analysis.
- Participate in cross-functional team meetings, present PK findings, and provide expert PK input to project teams.
Required Skills
- Master's or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, or a related quantitative scientific field.
- Minimum 3 years of experience in pharmacokinetic analysis within the pharmaceutical or biotechnology industry.
- Proficiency with pharmacokinetic modeling and simulation software (e.g., Phoenix WinNonlin).
- Strong understanding of clinical trial design, conduct, and regulatory requirements for drug development.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proven ability to communicate complex scientific information clearly and concisely, both orally and in writing.
- Ability to work independently, manage multiple projects, and collaborate effectively as part of a multi-disciplinary team.
Preferred Qualifications
- Experience with population PK analysis (e.g., NONMEM, MONOLIX).
- Familiarity with R or SAS for data manipulation, statistical analysis, and visualization.
- Prior experience in oncology, immunology, or cardiovascular therapeutic areas.
- Experience in writing sections of clinical study reports (CSRs) and regulatory submission documents (e.g., IND, NDA, BLA).
- Record of publications in peer-reviewed journals related to pharmacokinetics or clinical pharmacology.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance coverage.
- 401(k) retirement plan with generous company match.
- Generous paid time off, including vacation, holidays, and sick leave.
- Life and disability insurance programs.
- Professional development opportunities and tuition reimbursement for continuing education.
- Employee wellness programs and resources.
- Remote work flexibility, promoting work-life balance.
- Access to innovative research tools and technologies.
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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