医学总监

his position is responsible for the comprehensive management of the company's clinical department and clinical projects, providing strategic medical support and academic expertise throughout the clinical development lifecycle.The actual work location can be arranged for remote work based on the candidate's needs.
本岗位主要负责公司临床部门和临床项目的综合管理，并在新药研发的全生命周期中提供具有战略高度的医学支持与学术指导。办公地点可根据候选人需求，安排远程办公
一、核心职责 / Key Responsibilities
1、Comprehensive Management / 综合管理:
Oversee the comprehensive management of the company's clinical department and clinical projects.
负责公司临床部门和临床项目的综合管理。
2、Protocol Design & Expert Communication / 方案设计与专家沟通:
Lead the research and drafting of clinical trial protocols. Communicate with clinical and regulatory experts regarding protocol design, and provide academic support for protocol discussion and summary meetings.
负责临床医学专业项目的调研、临床试验方案撰写。根据临床项目的需求，与临床医学专家、审评专家进行临床方案设计相关的沟通，参与临床方案讨论会、总结会，并提供相关学术支持。
3、Clinical Academic Support / 临床学术支持:
Provide clinical academic support during the trial, including drafting, reviewing, and revising study records, CRFs, Informed Consent Forms (ICF), patient diaries, and Investigator's Brochures (IB).
负责临床试验项目开展过程中的临床学术支持，如研究病历、CRF、知情同意书、患者日记卡、研究者手册的撰写、审核及修订。
4、Regulatory Submission Support / 注册申报支持:
Draft, review, and revise clinical summary reports, clinical study overviews, and other clinical sections of regulatory submission documents.
负责临床总结报告、临床研究综述等临床部分注册申报资料的撰写、审核及修订。
5、Clinical Development Strategy / 临床开发策略:
Formulate and implement clinical development strategies for new drugs, providing academic support for new drug registration and clinical trials.
制定和实施新药的临床开发策略，为公司新药注册、新药临床试验提供学术支持。
6、Data Interpretation & Literature Support / 数据解读与文献支持:
Interpret clinical efficacy and safety data, and provide academic support through medical literature and information resources.
负责临床有效性及安全性的解读，并提供医学文献、信息等学术支持。
7、Safety & Pharmacovigilance / 安全性评估与药物警戒:
Evaluate adverse events and their impacts in clinical research, and be responsible for the collection, compilation, and reporting of safety information regarding the company's products.
评估临床研究的不良事件及其影响，负责对公司产品的安全信息的收集、整理、上报工作。
8、Other Medical Affairs / 其他医学事务:
Perform other medical affairs tasks as assigned. 负责其他医学事务。
二、任职资格 / Qualifications
1、Therapeutic Area Experience / 治疗领域经验:
Must have hands-on experience in Phase I-III clinical trials specifically related to Head and Neck Cancer.
必须具备包括头颈癌相关Ⅰ-Ⅲ期临床试验经验。
2、Educational Background / 学历与专业背景:
Master’s degree or above, majoring in Clinical Medicine, Basic Medicine, Pharmacy, or related fields.
硕士及以上学历，临床医学、基础医学、药学等相关专业。
3、Regulatory Knowledge / 法规与专业知识:
Solid understanding of clinical trial management processes, ICH-GCP, and NMPA regulatory requirements.
熟悉临床研究管理流程、ICH-GCP及NMPA相关法规要求。
4、Medical Writing & Communication / 医学撰写与沟通能力:
Excellent medical writing skills and strong ability to communicate with KOLs and regulatory authorities.
具备出色的医学撰写能力，以及与KOL和监管机构沟通的能力