• Associate Director, CPMS

• Director, CPMS

• Senior Director, CPMS

And the following roles in our other global locations:

• PK Scientists

• Senior PK Scientists

• Associate Director, CPMS

• Director, CPMS

• Senior Director, CPMS

• Depth of experience and relevant experience will determine level of role.
• Excellent written and verbal English communication skills are required. Chinese language skills are a plus.
• 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

• 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