Pharmacokineticist I
Fortrea’s Clinical Operations team is recruiting for a Pharmacokineticist. You will join a global team and have the opportunity to work across a number of compounds across Phase I studies. In a versatile opportunity, you will work closely with a variety of different Sponsors, being responsible of Pharmacokinetic deliverables across a number of projects.
We are looking for a Pharmacokineticist / Clinical Pharmacologist who will be involved in reviewing study designs, providing input to Statistical Analysis Plans, performing/reviewing PK/PD data analyses and providing accurate interpretation of data. You will also contribute to project management activities and have the opportunity to assist with proposal activities.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
Duties will include:
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 Labcorp 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.
Contribute to proposal activities and client presentations.
Provide PK(/PD) guidance and consultancy in development of clinical research program and in design of individual studies as part of multi-disciplinary team.
Ideally you will have the following experience/skills:
Postgraduate experience in the application of PK and PD to clinical trials, ideally within a CRO.
Bachelor’s degree in Bioanalytical Chemistry or a Biological Life Science field.
Proficient in compartmental/non-compartmental data analysis.
Proficient in PK/PD analysis tools WinNonLin and NONMEM.
Effective interpersonal and communication skills
Cooperative, team-oriented and proactive.
Ability to work in tight deadlines while maintaining high quality standards.
Good knowledge of Clinical Development.
Competence in the preparation of Pharmacokinetic Analysis Plans, 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 company as a business.
#LI-Remote, Remote
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
