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：
任职要求：
工作地点：美国波士顿，中国上海、北京
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