Senior Clinical Pharmacokineticist & Clinical Pharmacokineticist II

<h2>Job Overview:</h2><p style="margin: 0cm 0cm 8pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Labcorp Drug Development are seeking a Pharmacokineticist to join our Clinical Pharmacology Services department. The Pharmacokineticist is responsible for Analysing and reviewing data and offering scientific advice.</span></p><p style="margin: 0cm 0cm 8pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong><span style="color: black;">Your duties will include but not be restricted to:</span></strong></span></p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Fulfill the role of a study Pharmacokineticist:</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for PK(/PD) deliverables within assigned projects.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for development of PK(/PD) Analysis Plans, to include methodology, </span><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">definition of derived variables, and data-handling rules.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Conduct or review/QC interim PK(/PD) analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Conduct or review/QC non-compartmental PK and PD analyses as specified in the report and analysis plans.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Conduct modeling/simulation of PK, PD, and PK/PD data and provide interpretation of the results.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for PK(/PD) input to reports including Clinical Study Reports.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Independent peer review of PK and PD deliverables (e.g., protocols, Analysis, Plans, PK reports, Clinical Study Reports).</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Carry out all activities according to appropriate Labcorp SOPs, working within the framework of the Quality Management System and to GCP.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Contribute to review and amendment of departmental processes and supporting documentation. Provide PK input into other disciplines’ activities and participate in interdepartmental processes.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Project management activities for identified projects including financial, resource planning and utilization, timelines, and milestone management.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Represent Pharmacokinetics in internal and external audits.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Supervision and training of less-experienced Pharmacokineticists within project activities.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Contact with client across multiple disciplines.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Contribute to proposal activities and client presentations.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10pt; color: black; font-family: arial, helvetica, sans-serif;">Get ready to redefine what’s possible and discover your extraordinary potential at Labcorp Drug Development. 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.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt; color: black; font-family: arial, helvetica, sans-serif;">Join us and discover why Labcorp Drug Development has been named by FORTUNE as one of the World's Most Admired Companies 2021 for the third consecutive year 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.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;">REMOTE</p><h2>Education/Qualifications:</h2><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Bachelor’s degree in Bioanalytical Chemistry or a Biological Life Sciences degree required.</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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.</span></li><li><strong><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Proficient in compartmental /non-compartmental data analysis.</span></strong></li><li><strong><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Knowledge of sophisticated PK(/PD) analysis tools such as WinNonLin and NONMEM.</span></strong></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Effective interpersonal and communication skills.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Cooperative, team-oriented and proactive.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Self-motivation.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">The ability to work to tight deadlines while maintaining high standards.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to adhere to strict guidelines and codes of practice.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">A good knowledge of Clinical Development.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Competence in the preparation of Pharmacokinetic Analysis Plans, analysis, reporting, etc., across a variety of trials.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to explain PK and PD concepts to non-pharmacokineticists.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">An evident appreciation of the possible impact of day-to-day activities and actions on Labcorp as a business.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">A professional approach at all times.</span></li></ul><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">#LI-SP2</span></p>