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Sr Pharmacokineticist

Sr Pharmacokineticist
Company:

Covance By Labcorp


Details of the offer

Job Overview:

***Remote role***
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.

Education/Qualifications:

Bachelor’s degree in Bioanalytical Chemistry or a Biological Life Sciences degree required.

Experience:

Minimum 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.
Self-motivation.
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

#LI-ML1
#LI-REMOTE


Source: Appcast2

Job Function:

Requirements

Sr Pharmacokineticist
Company:

Covance By Labcorp


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