Typical Accountabilities

·     Ensure the optimal application of clinical pharmacokinetics (PK), pharmacodynamics (PD), and modelling & simulation (M&S) in clinical development programs, including:

1.     Design and conduct clinical studies including CP studies (dosing rationales, sampling schemes, etc.)

2.     Data analyses (e.g., M&S) to elucidate dose-exposure-response relationships, and result interpretations

3.    Play a central role in justifying dose recommendations for Asian population by using quantitative approaches

4.    Promote M&S approaches in clinical development programs whenever applicable

5.    When applicable, develop mathematical and statistical models to understand disease mechanism, its progression, and PK/PD; conduct meta-analyses as appropriate to maximize data use.

6.     Preparation and defence of regulatory submissions, as well as regulatory interactions such as end of phase consultation meetings, query response, etc.

·    Interact with internal and external stakeholders for assigned projects

·    Literature research and knowledge sharing; publish clinical pharmacology-related research articles and reviews in peer-reviewed journals, when applicable

·    Train junior CP staff

Education, Qualifications, Skills and Experience

Essential

• Advanced training with a degree such as PhD, PharmD, and MD to enable a successful career in the field.  Applicant with a master’s degree should have a strong technical background and have been successfully delivering the drug development projects before.    
• Experienced in drug clinical development
• Proficiency in oral and written mandarin and English;
• Capability to provide own learnings, ideas, and experiences to internal stakeholders
• Excellent communication, analytical and problem-solving skills
• Experience with both early and late phase clinical development

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.