锦鲤求职岗位描述
Major Responsibilities：
1. Function as clinical pharmacology representative in the project team and support clinical pharmacology-related activities in clinical studies, including protocol design, study implementation, data analysis, reports writing and regulatory submissions, etc.
2. Coordinate and monitor clinical pharmacology data to ensure all execution is in line with departmental strategy, in compliance with regulatory and legal requirements, and company standard operating procedures.
3. Conduct pharmacokinetic (PK)/pharmacodynamic (PD) and dose-exposure-response analysis to support dose selection, trial design, internal decision-making, regulatory submissions, and published articles.
4. Provide advice for preclinical stage projects to optimize in vitro and preclinical data, support projects to advance clinical development and submit new drug applications.
5. Writing clinical pharmacology-related documents, oral communication and presentation in Chinese and English, etc.
Qualifications：
1. Degree requirements: Master or above
2. Major requirements: pharmaceutical science, pharmacokinetics, clinical pharmacology, quantitative pharmacology, biomedical engineering or related fields
3. Working experience: more than 1 year working experience of clinical pharmacology in pharmaceutical companies or CRO companies
4. Capability requirements:
(1) Have strong execution ability;
(2) Strong independent scientific research ability, logical thinking, and coordination/problem-solving skills;
(3) Have clear written and oral communication skills;
(4) Have a good team spirit;
5. Skill requirements:
(1) Understand the role of clinical pharmacology in clinical trials and drug development
(2) Familiar with regulatory requirements and guidelines of clinical pharmacology
(3) Familiar with pharmacokinetic software (such as Phoenix WinNonlin); knowledge and skills of PK/PD modelling and simulation software (such as NONMEM, R, etc.) are a plus.
(4) Good project management skills, and the ability to collaborate with other departments and manage with internal and external partners.