- Contract Type
A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient’s lives. Joining Covance will offer a rewarding career, a chance to work in a high-energy & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting.
Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
Essential Position Duties
Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK and PD analysis and study objectives.
Supervision of less-experienced Pharmacokineticists within project activities.
Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
Responsible for development of PK Analysis Plans, to include methodology, definition of derived variables and data-handling rules.
Responsible for PK/PD deliverables within assigned projects and input to reports including Clinical Study Reports (CSRs)
Conduct non-compartmental PK/PD analysis as specified in the report and analysis plans and perform QC/review of analysis.
Conduct compartmental modeling/simulation of PK, PD and PK/PD data and provide interpretation of the results.
Provide PK/PD mentorship in development of clinical research program and in design of individual studies as part of multi-disciplinary team.
Conduct independent peer review of protocols, Analysis Plans, PK reports, and CSRs
Contribute to review and amendment of departmental processes and supporting documentation.
Project management activities for identified projects including financial, resource planning and utilization, timelines and achievement management.
Conduct interim PK and PD analyses, interpret the data and attend dose issue teleconferences to support dose progression in allocated studies.
Contact with client across multiple disciplines, contribute to proposal activities and presentations, along with representing the department during client audits.
Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
Education and Experience Requirements
Relevant 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 (minimum).
Previous CRO experience is preferred but not essential
Strong knowledge of Clinical Development.
Proficient in compartmental/non-compartmental data analysis.
Specialist in WinNonLin.
Effective interpersonal and communication skills.
Cooperative, self-motivated, and have a can-do attitude.
The ability to work to tight deadlines while maintaining high standards.
Ability to adhere to strict guidelines and codes of practice.
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 while keeping a professional approach at all times.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
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