Job Description

Job Description

Job Responsibilities:

1. Lead the formulation and execution of clinical development plans and trial protocols based on scientific principles, regulatory guidelines, market positioning, expert advice, patient rights, and the company's overall strategy. Effectively monitor, make timely adjustments, and provide support for future market access.

2. Establish and strengthen good interactive relationships with regulatory authorities, public health organizations, and influential institutions or individuals in the medical and industry fields, and transform these relationships into driving forces for the company's pipeline clinical development.

3. Be responsible for the analysis, reporting, and interpretation of clinical research data, ensuring the right direction and progress.

4. Be responsible for the preparation or verification of relevant regulatory and submission documents.

5. Provide medical support for the planning of the company's preclinical product pipeline and future clinical development strategies.

6. Develop a publication plan for clinical development progress, present clinical data at important conferences, and publish in high-level journals.

Job Requirements:

1. Doctor of Medicine, with over 20 years of industry experience.

2. Successful experience in leading the clinical development of innovative targeted anti-tumor drugs and non-tumor drugs, including the design, execution, and completion of clinical trials at different stages.

3. Understanding of global regulatory requirements. Those with later-stage interactions with regulatory authorities (successful NDAs/MAAs, etc.) or overseas experience are preferred.

4. Possess creative and comprehensive thinking, and be able to rationally formulate executable clinical development plans based on the company's strategic goals and scientific basis.

5. Have practical leadership skills, be able to effectively build and manage the corresponding execution team, and demonstrate both in medical functions and operational levels.

6. Be proactive and collaborative, able to inspire and motivate cross-functional team members to achieve common goals.

Work Location: Boston, USA; Shanghai and Beijing, China

岗位职责：

1. 领导制定和执行基于科学原理、监管准则、市场定位、专家建议、患者权益和公司整体战略的临床开发计划与试验方案，有效监控、适时调整，并为未来的市场准入提供支持；
2. 建立和加强与监管机构、公共卫生组织和医疗、行业专家等有影响力的机构或人物的良好互动关系，并将这种关系转化为公司管线临床开发的推动力；
3. 负责临床研究数据的分析、报告与解读，把握方向和进度；
4. 负责相关监管和申报文件的准备或核查；
5. 为公司临床前产品管线的规划和未来临床开发策略提供医学支持；
6. 制定临床开发进展的出版计划，在重要会议上展示临床数据并在高水平期刊上发表；

任职要求：

1. 医学博士，20年以上行业经验；
2. 领导创新性靶向抗肿瘤药物、非肿瘤药物的临床医学的成功经验，包括不同阶段临床试验的设 计、执行和完成；
3. 了解全球监管要求，有与监管机构后期互动（成功的 NDA/MAA 等）或海外经 验者优先；
4. 有创造性和综合性思维，能以公司战略目标为导向、以科学为基础，合理制定 可执行的临床开发计划；
5. 有实践领导能力，能有效组建和管理相应的执行团队，既能在医学职能上体 现，也能在运营层面上把控和执行；
6. 具有主动性和协作精神，能启发和激励跨职能团队成员实现共同目标；

工作地点：美国波士顿，中国上海、北京

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