- Experience Level
- Experienced (non-manager)
Permanent position available to join our Clinical Pharmacology Services division as a Senior Pharmacokineticist. COVANCE is a leading global drug development services company providing support to the Pharmaceutical and Biotechnology industries. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner.
Your duties will include but not be restricted to:
- 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.
We Offer the opportunity to work within an experienced and highly skilled team and together with Covance’s ongoing success offer you the prospect of unsurpassed growth and career development opportunities.
Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us and see why LabCorp/Covance have been named by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.
- 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.
- Proven people management or supervisory experience.
- 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.
- A professional approach at all times.