1、硕士及以上学历，临床医学等相关专业

2、在药企或者CRO有4年以上临床研究相关工作经验，其中医学撰写工作经验至少2年，有Pre-IND、IND、NDA申报经验优先；

3、具有扎实的医学基础知识，熟悉药物Ⅰ-Ⅲ临床试验方案设计，熟悉掌握国内外文献的查阅、整理和分析；

4、熟悉临床试验流程及国内外相关法律法规；

5、熟练的英文听、说、读、写能力

1. Master degree or equivalent with 4+ years' clinical drug development experience in the biopharma industry environment or CRO.

2. Strong scientific and translational abilities as demonstrated through past experience and/or academic research as evidenced by applying novel drug mechanism of action to address relevant human pathology.

3. Successful records of independently lead early clinical development from first in human (FIH) through proof of concept (POC) for one or more projects in biopharma industry

4. Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations,experienced in phase I,II,III studies.

5. Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials. Significant experience working on, with and leading cross-functional project/program teams.

1、根据中心的研发策略，收集和整理医学信息和资料，及时跟踪并推送相关领域的临床研究及医学进展，并对新立项或引进项目提供临床方面评估意见；

2、协同中心内外部资源，并与相关专家讨论，对新药、器械项目制定科学可行的临床开发策略；

3、根据药物、器械临床前研究结果及国内外同类药物研发情况撰写临床综述、研究者手册等，并与相关专家讨论，确定和完善临床研究方案；

4、负责临床研究项目中的知情同意书、试验方案、总结报告等相关文件的撰写及医学监查；

5、负责新药、器械试验项目中与CDE及临床专家沟通及各项会议的参与，确保临床研究的可行性及科学性；

6、协调、组织或参与临床研究项目讨论会、启动会、总结会等，并提供学术支持；

7、临床研究过程中相关数据的监测审核，包括AE、SAE等医学审核。

8、完成上级交办的其他临时任务；

1. Leads or participates in the development of the Bay Trial center’s clinical research strategy and portfolio.

2. Manages the clinical development component in the preparation/review of regulatory documents, including urgent information requests, investigator brochures, clinical study reports.

3. Leads and drafts clinical trial protocol design, ICF, clinical study reports and response to health authority inquiries.

4. Provides scientific and clinical guidance to cross-functional teams and colleagues to meet early development project deliverable and timelines.

5. Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.

6. Conducts analysis of ongoing data for internal analysis and review and ensures appropriate data cleaning and integrity.

7. Review of data listings, summary tables, study results.

8. Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.

9. Develops manuscripts for publication in peer-reviewed journals and presents scientific information to clinical study investigator at appropriate meetings.

10. Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Bay Trial SOPs.

11. Provides clinical guidance and training to the center Clinical Operations, Biomarkers, Clinical Pharmacology, Biometrics, Patient Safety, Regulatory, and Project Management staff.

12. Frequent, direct contact with study sites and investigators. Identify and map KOLs, investigators and research centers within the relevant therapy areas, and engage with them regularly to gather valuable medical insights.