LabCorp Bioanalytical Chemistry Pharmacokineticist Vacancy
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Job Title: Pharmacokineticist I
Category Clinical Location Bangalore, India
Job Id: 2325866
Job Type Full-Time
Minimum Eligbility Criterua & Experience:
- 3+ years of postgraduate experience in the application of PK and PD to clinical trials
- Bachelors degree in Bioanalytical Chemistry or a Biological Life Science field
- Proficient in compartmental/non-compartmental data analysis
- Proficient in PK/PD analysis tools WinNonLin and NONMEM
- Effective interpersonal and communication skills
- Cooperative, team-oriented and proactive
- Self-motivated
- Ability to work in tight deadlines while maintaining high quality standards
- Ability to adhere to strict guidelines and codes of practice
- Good knowledge of Clinical Development
- Competence in the preparation of Pharmacokinetic Analysis Plans, reporting, etc., across a variety of trials
- Ability to explain PK and PD concepts to non-pharmacokineticists
- An evident appreciation of the possible impact of day-to-day activities and actions on company as a business.
Job Responsibilities
- Liaise with the relevant bioanalytical departments over the transfer and quality of PK and PD data.*
- Fulfill the role of a study Pharmacokineticist:
- Responsible for PK(/PD) deliverables within assigned projects.
- Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives.
- Responsible for development of PK(/PD) Analysis Plans, to include methodology, definition of derived variables and data-handling rules.
- Conduct or review/QC interim PK(/PD) analyses, interpret the data and attend dose escalation teleconferences to support dose progression in allocated studies.
- Conduct or review/QC non-compartmental PK and PD analyses as specified in the report and analysis plans.
- Conduct modeling/simulation of PK, PD and PK/PD data and provide interpretation of the results.
- Responsible for PK(/PD) input to reports including Clinical Study Reports.
- Independent peer review of PK and PD deliverables (e.g., protocols, Analysis Plans, PK reports, Clinical Study Reports).
- Carry out all activities according to appropriate SOPs, working within the framework of the Quality Management System and to GCP.
- Contribute to review and amendment of departmental processes and supporting documentation. Provide PK input into other disciplines’ activities and participate in interdepartmental processes.
- Represent Pharmacokinetics in internal and external audits.
- Perform other duties as requested by management.
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Important Interview Questions and Answers for the above job role:
- Can you describe your experience in conducting PK/PD analysis for clinical trials? Answer: Yes, I have over 3 years of postgraduate experience in the application of PK and PD to clinical trials. I have conducted or reviewed/QC interim PK/PD analyses, non-compartmental PK and PD analyses, and modeling/simulation of PK, PD, and PK/PD data. I also have experience in developing PK/PD analysis plans and providing PK/PD input into reports including Clinical Study Reports.
- How do you ensure the quality of PK/PD data during clinical trials? Answer: As a Pharmacokineticist, I liaise with relevant bioanalytical departments over the transfer and quality of PK and PD data. I conduct or review/QC interim PK/PD analyses, non-compartmental PK and PD analyses as specified in the report and analysis plans. I also contribute to the review and amendment of departmental processes and supporting documentation to ensure adherence to GCP and appropriate SOPs.
- How do you handle tight deadlines while maintaining high-quality standards in your work? Answer: I am self-motivated and proactive, which enables me to work efficiently under tight deadlines. I also prioritize my tasks and ensure I have a clear understanding of the objectives and deliverables for each project. I pay close attention to details and double-check my work to ensure that it meets high-quality standards.
- Can you explain a PK/PD concept to a non-pharmacokineticist? Answer: Sure, PK refers to the study of the time course of drug absorption, distribution, metabolism, and excretion in the body. PD, on the other hand, refers to the study of the drug’s effects on the body. PK/PD analysis involves the evaluation of the relationship between drug exposure and its pharmacological effects. This analysis helps to determine the optimal dose of the drug and its safety profile.
- How do you contribute to interdepartmental processes in your role as a Pharmacokineticist? Answer: I provide PK input into other disciplines’ activities such as clinical study design and statistical analysis. I also collaborate with other departments such as bioanalytical, medical writing, and regulatory affairs to ensure that PK/PD analysis is integrated into the overall clinical development plan. In addition, I represent Pharmacokinetics in internal and external audits, contributing to the continuous improvement of departmental processes.
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