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Your main responsibilities will include but not be restricted to:
- 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 Sponsor’s 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 Covance 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.
- Contribute to proposal activities and client presentations.
- Bachelor’s degree in a Bioanalytical Chemistry or a Biological Life Sciences degree.
- Typically, a minimum of 3 years of experience in clinical pharmacokinetic and/or pharmacodynamic analysis.
- Good knowledge of non-compartmental pharmacokinetic analysis, drug metabolism and physiological processes.
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Vacancy Type: Full Time
Job Location: Belgrade, Serbia
Application Deadline: N/A