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Senior PK Scientist
Parexel International Corporation
Germany, Remote
Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally! We are currently seeking a Senior PK Scientist to join our team and help our clients reduce the time to bring new treatments to patients. Qualifications:Depth of experience and relevant experience will determine level of role.
Excellent written and verbal English communication skills are required.
Advanced science degree (PhD, PharmD, MSc) and/or relevant experience
Significant experience in clinical drug development of both NCEs and biologicals
Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
Experience using Phoenix WinNonlin to conduct non-compartmental and compartmental analysis.
Experience using other software such as NONMEM, GastroPlus or R are desirable.
Strong non-compartmental analysis experience
Previous popPK and/or PBPK experience are a plus.
Excellent interpersonal, verbal and written communication skills
Extensive clinical/scientific writing skills
Client focused approach to work ethic.
Exhibits and promotes a flexible attitude with respect to work assignments and new learning.
Ability to direct and manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Willingness to work in a matrix environment and to value and promote the importance of teamwork.
Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
Knowledge And ExperienceSignificant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired
Acknowledged as an expert in the industry for more senior roles.
Demonstrated knowledge of regulatory environment as it relates to CPMS and Drug Development
Depth of experience and relevant experience will determine level of role.
Excellent written and verbal English communication skills are required.
Advanced science degree (PhD, PharmD, MSc) and/or relevant experience
Significant experience in clinical drug development of both NCEs and biologicals
Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
Experience using Phoenix WinNonlin to conduct non-compartmental and compartmental analysis.
Experience using other software such as NONMEM, GastroPlus or R are desirable.
Strong non-compartmental analysis experience
Previous popPK and/or PBPK experience are a plus.
Excellent interpersonal, verbal and written communication skills
Extensive clinical/scientific writing skills
Client focused approach to work ethic.
Exhibits and promotes a flexible attitude with respect to work assignments and new learning.
Ability to direct and manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Willingness to work in a matrix environment and to value and promote the importance of teamwork.
Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
Knowledge And ExperienceSignificant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired
Acknowledged as an expert in the industry for more senior roles.
Demonstrated knowledge of regulatory environment as it relates to CPMS and Drug Development
Significant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired
Acknowledged as an expert in the industry for more senior roles.
Demonstrated knowledge of regulatory environment as it relates to CPMS and Drug Development
Job posted: 2023-05-25
