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CPMS Director

Parexel International Corporation

China - Any Region - Home Based

Key Accountabilities:

• To work with clinical teams to design PK/PD components in various study designs in different therapeutic areas

• To analyze clinical PK/PD data as a member of several multidisciplinary development program teams for understanding of PK/PD relationship for drug effect and dose selection

• Responsible for authoring or contributing to clinical PK/PD sections of relevant documents such as clinical study protocols, statistical analysis plans, and clinical study reports

• Participate in project meeting, and actively involved in data analysis, data interpretation, and issue solvingQualificationsQualifications:

Education and Experience

• Master of Science degree or above in clinical pharmacology, pharmaceutical sciences, or other life science

• At least 3 years direct industry experience in Clinical Pharmacology

Skills

• Strong knowledge of PK and PD principles

• Experience with the design and implementation of Model-Based Drug Development strategies

• Solid Experience in PK and PD data analysis using Phoenix WinNonlin

• Experience in other software such as NONMEM, GastroPlus and R is desirable

• Experience in clinical drug development of both small molecules and biologics

• Excellent verbal and written communication, interpersonal and problem-solving skills

• Strong 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 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.

• Understanding of the drug development process and a knowledge of China, US, EU, or other countries/regions regulatory requirements and guidelines

• Fluent in Chinese and English both in verbal and written

Job posted: 2021-02-03

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