- Provide PK(/PD) guidance and consultancy in development of clinical research program and in design of individual studies as part of multi-disciplinary team.
- 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 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.
- Project management activities for identified projects including financial, resource planning and utilization, timelines, and milestone management.
- Represent Pharmacokinetics in internal and external audits.
- Supervision and training of less-experienced Pharmacokineticists within project activities.
- Contact with client across multiple disciplines.
- Contribute to proposal activities and client presentations.
- Perform other duties as requested by management.
- Bachelor’s degree in Bioanalytical Chemistry or a Biological Life Sciences degree required.
- 5 years of postgraduate experience in the application of PK and PD to clinical trials for employees with a BSc in the field of Bioanalytical Chemistry or a Biological Life Sciences Degree.
- Proficient in compartmental /non-compartmental data analysis.
- Knowledge of sophisticated PK(/PD) analysis tools such as WinNonLin and NONMEM.
- Effective interpersonal and communication skills.
- Cooperative, team-oriented and proactive.
- The ability to work to tight deadlines while maintaining high standards.
- Ability to adhere to strict guidelines and codes of practice.
- A good knowledge of Clinical Development.
- Competence in the preparation of Pharmacokinetic Analysis Plans, analysis, 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 Covance as a business
- professional approach at all times
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