מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר
Job Description
Key Tasks
• Lead the design and development of clinical pharmacology programs (including small and large molecules) to support R&D China regulatory submissions and approvals.
• Oversee protocol preparation, data review and analysis, and study reports for China PK studies across various disease areas.
• Provide strategic input and guidance for clinical pharmacology aspects of phase 3 studies and China regulatory documents in alignment with global standards and processes.
• Ensure delivery of high-quality evaluation and interpretation of clinical pharmacology data, including pharmacokinetics, pharmacodynamics, safety, and dose/concentration response.
• Engage with investigators on scientific issues and serve as the primary China liaison with Global Clinical Pharmacologists for assigned projects.
• Act as a core member of the China Project Team, contributing to all clinical PK and PK/PD aspects of development projects and programs.
• Provide quantitative pharmacology and modeling & simulation support for clinical development projects.
• Assist in evaluating in-licensing opportunities related to clinical PK and PK/PD components.
• Contribute to the identification, characterization, and validation of potential biomarkers and surrogate markers in non-clinical and clinical studies.
Academic / Professional Qualification
• PhD degree in Pharmacology, Pharmaceutics, or related disciplines (or equivalent degree/knowledge/expertise).
Technical / Skills Training
• Fluent in written and spoken English.
• Extensive expertise and comprehensive understanding of Clinical Pharmacology aspects of drug development.
• Proven pharmaceutical R&D experience with expert knowledge of pharmacokinetics and its clinical application.
• In-depth understanding of early and late clinical programs in Clinical Pharmacology, including modeling and simulation.
Working Experience
• 10+ years of experience in clinical pharmacology in a multi-national pharmaceutical industry.
• People management experience is required.
• Proficiency in the use of WinNonlin, NONMEM, R or S-plus, database management, and related scientific software.
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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