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 Labcorp 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.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
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