临床药理研究员（临床医学部）

1、应用NONMEM，R，SAS语言等行业标准软件进行或协助进行群体药动学分析和PK/PD分析。

Conduct or contribute to population PK modeling and simulation and PK/PD analysis using NONMEM, R and SAS or other industry standard software tools.

2、应用建模与模拟方法优化临床试验设计，预测药物吸收，分布，代谢和排泄特征及内在和外在因素对PK的影响，探索剂量效应关系，推荐给药方案和说明书制定，桥接不同人群和种族。

Optimization study design，predicting and characterizing absorption, distribution, metabolism, and excretion, including intrinsic and extrinsic factors impacting PK variability，exploring the dose response relationship, dose and schedule selection and label recommendations，bridging between populations and ethnicities by modeling and simulation.

3、应用Phoenix WinNonlin？进行非房室模型和房室模型分析。

Contribute to non-compartmental and compartmental pharmacokinetic analysis using Phoenix WinNonlin？.

4、进行临床药理相关（包括初次人体起始剂量及有效剂量预测，剂量爬坡、PK/PD采血点等）的方案设计、数据分析和结果分析，优化PK采血和给药剂量。

Conduct the design, analysis, and interpretation of clinical pharmacology studies (FIH dose prediction, PK/PD sampling) and provide guidance to optimize pharmacokinetic sampling and dosing strategies.

5、撰写INDs、NDAs申报材料中的临床药理相关部分。

Prepare clinical pharmacology/pharmacokinetic sections of submission documents for INDs, NDAs etc.

6、临床相关文献收集和分析用以方案设计。

Collect and summarize research papers for project design.

7、参与部门内部相关培训工作。

Provide trainings to department staff.

8、协助完善定量药理和临床药理相关的质量体系包括但不限于SOP和各种模板。

Assist with pharmacometrics and clinical pharmacology quality system set up including but not limited to SOP and templates generation.

岗位要求：

1、硕士及以上学历，药学、临床药理或DMPK专业,硕士具有2-4年、博士具有2年临床药理或定量药理工作经验 。

Master degree or above in pharmacy, clinical pharmacology or DMPK (Drug Metabolism & Pharmacokinetics).

2、有NONMEM，R，WinNonlin，SAS或其他建模和模拟软件的使用经验。

Experience with NONMEM, R,Phoenix WinNonlin,SAS or other modeling and simulation software tools.

3、有群体PK和PK/PD建模相关知识，实操经验。

Knowledge of population pharmacokinetic modeling and PK/PD modeling, hands on experience.

4、优先有ADC 建模经验候选者。

Prefer the hands on experience PopPK E-R analysis of ADC products.