以上为北京时间。链接检查不代表仍在招聘，申请前请以招聘官网为准。
按这个岗位的城市和方向提醒，确认后才开启，可选择每日或每周。
该职位负责抗体偶联药物（AXC）癌症治疗的临床开发领导工作。主要职责包括：为IND申报及早期临床试验提供医学科学指导，监督临床试验安全性，撰写方案与知情同意书，领导临床研究报告设计及分析，监督CRO合作伙伴运营，跟进行业前沿进展。要求具备GCP/ICH知识及跨部门战略协作能力。
We are seeking a highly motivated leader to join our dynamic research team focusing on the development of Antibody-X Conjugate (AXC) therapies to revolutionise cancer treatments. The successful candidate will play a pivotal role in overseeing the direction, planning and execution of our clinical development programs.
Key Duties &
Responsibilities:
- Provides expert medical and scientific guidance to strategically plan and execute IND filings and early-stage clinical trials.
- Performs medical oversight of clinical trials, drafts protocols and informed consent documents, and addresses queries from regulatory bodies, IRBs, and ethics committees. Reviews clinical data and ensures accuracy for final clinical study reports.
- Monitors safety throughout trials, ensures adherence to company standards and regulatory requirements (GCP/ICH), and supports development of investigator brochures.
- Leads the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and study-related documents.
- Supervises clinical research operations conducted by CRO partners.
- Maintains current knowledge of industry advancements and therapeutic areas through conferences, literature, and training.
- Collaborates closely with stakeholders to align product development plans and strategies strategically.
- M.D. or equivalent with a minimum 3 years of experience is required
- Experience in clinical oncology will be preferred
- Demonstrated experience in global clinical trials, with specific experience in the US region
- Proven track record of effectively managing Phase 1 and/or 2 Oncology clinical trials.
- Strong organizational skills with meticulous attention to detail
- Excellent verbal and written communication skills
- Demonstrated leadership in leading cross-functional project teams
- Effective management and leadership skills
- Ability to work both independently and collaboratively within a dynamic biotech startup environment
医药制造业
