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u 工作職責(zé)：

1. 設(shè)計(jì)并撰寫早期臨床試驗(yàn)提案、方案和報(bào)告，尤其是臨床藥理學(xué)和生物標(biāo)志物相關(guān)章節(jié)。

2. 參與項(xiàng)目重大決策，參與臨床項(xiàng)目的制定和實(shí)施，以及法規(guī)相關(guān)文件的編寫。

3. 負(fù)責(zé)臨床藥理學(xué)相關(guān)數(shù)據(jù)分析，包括PK和PK-PD分析。

4. 通過設(shè)計(jì)臨床試驗(yàn)，促進(jìn)投標(biāo)過程。為臨床研究方案和其他核心研究提供輸入。

5. 審查非臨床數(shù)據(jù)和指南，以確定首次人體研究的起始劑量。提供第1階段研究中劑量遞增和劑量范圍的基本原理。

u 任職資格：

1. 藥理學(xué)或相關(guān)領(lǐng)域的博士、碩士或碩士學(xué)位，至少2年藥物發(fā)現(xiàn)和開發(fā)相關(guān)研究經(jīng)驗(yàn)。

2. 在DMPK、生物學(xué)、藥理學(xué)和臨床研究方面有較強(qiáng)的背景。有藥品研發(fā)經(jīng)驗(yàn)者優(yōu)先。

3. 熟悉CFDA法規(guī)和CDE新藥注冊(cè)審評(píng)要求。

4. 必須具備流利的英語(yǔ)口語(yǔ)和書面表達(dá)能力。擅長(zhǎng)撰寫臨床試驗(yàn)方案和總結(jié)報(bào)告。

5. 強(qiáng)烈的動(dòng)機(jī)、對(duì)細(xì)節(jié)的關(guān)注、獨(dú)立思考的能力，以及充分融入高績(jī)效團(tuán)隊(duì)環(huán)境的能力。

崗位職責(zé):

1.Design and write early clinical trial proposal, protocol, and report, especially clinical pharmacology and biomarker related sections.

2.Participate in project major decision making, involve in clinical program development and implementation, as well as regulatory related document writing.

3.Responsible for clinical pharmacology related data analysis, including PK and PK-PD analysis.

4.Review and provide input into departmental SOPs.

5.Facilitate the bidding process with designing the clinical trial.

6.Provide input into clinical study protocols, and other core study.

7.Review nonclinical data and guidelines to determine the starting dose for first in human studies. Provides a rationale for dose escalation and dose range in phase 1 studies.

任職要求:

?PhD, MD, or Master Degree in pharmacology or related field, with minimum of 2 years relevant research experience in drug discovery and development, preferably in a pharmaceutical setting.

?Strong background in DMPK, biology, pharmacology and clinical research. Experience in Class I drug R&D is a plus.

?Familiar with the CFDA regulations and CDE new drug evaluation requirements for registration.

?Fluent in English, both oral and written, is a must. Good at writing clinical trial proposal and summary report.

?Must be able to multi-task and participate effectively in teams.

?Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment.

?Read, write, and speak fluent English and Mandarin is required.