转化医学部总监
Job Responsibility Summary /岗位职责概述：
Responsible for formulating and maintaining development plan of translational medicine department , and conducting daily management, overall planning and technical guidance for department personnel. Provide input on transition of different drug candidates from the laboratory to humans and full implementation of early clinical studies. Participate in and support the business development team responsible for the project, and provide quotations and bidding-related materials for projects to support the company's strategic development. Keep paying attention to the latest research information at home and abroad, provide translational medicine consulting and training for internal team.
负责制定并维护转化医学部门发展规划，对部门人员工作进行日常事务的管理、统筹安排及技术指导。为不同项目候选药物从实验室向临床转化以及早期临床研究的全面实施提供转化医学专业建议。参与并支持商务拓展团队负责的项目，并为项目提供报价及竞标相关材料，支持公司的战略发展。持续关注领域内国内外最新研究信息，为团队内部提供转化医学专业知识咨询与培训。
Job Responsibilities Description /岗位具体职责：
1、Job Responsibilities /工作职责：
Provide input on target selection, target validation, and pre-clinical development of products, including but not limited to assess unmet medical need for the indications of products, review non-clinical research data and provide insight into possible clinical implications, provide input on the likely use of compounds by physicians and patients, propose likely clinical development plans;
为产品的靶点选择、靶点验证和临床前开发提供意见，包括但不限于评估产品适应症未满足的医疗需求，**非临床研究数据并深入了解可能的临床意义，对医生和患者可能使用产品的可能性提供意见，提出可能的临床开发计划；
Develop and implement the compound-related biomarker strategies;
制定和实施与化合物相关的生物标志物策略;
Develop and implement strategies to achieve clinical Proof of Concept (PoC) for early projects;
为早期项目制定和实施实现临床概念验证的策略；
Supervise the clinical team in designing, initiating, conducting and analyzing the data from first-in-human and proof-of-concept studies;
监督临床团队设计、启动、实施和分析来自首次人体试验和概念验证研究的数据；
Supply medical support for relevant pharmacokinetic studies;
为相关药代动力学研究提供医学支持；
Provide translational medicine advice for internal team, including but not limited to evaluate the feasibility of the project, integrity of non-clinical data, stimate the specification of the preparation, early clinical study design, provide strategic decision-making for clinical development plan, review the scientific/legal compliance and feasibility of the protocol;
向内部合作方提供转化医学建议：包括但不限于评估立项的可行性、非临床数据的完整性、制剂规格的估算、早期临床研究方案设计、为临床发展计划提供战略决策、**方案的科学/法律合规性和可行性；
Provide translational medicine consulting for internal team;
为团队内部提供转化医学咨询专业知识；
Lead or promote commercialization projects, including excavating customer needs before kick-off meeting, and visiting by Medical Experts, etc.
主导或推动商业化项目，包括项目立项前挖掘客户需求、医学项目的专家拜访等。
2、Personnel Management /人员管理职责：
Determine and adjust the development direction of the Department, and be fully responsible for daily personnel management, quality and policy compliance;
制定并调整部门发展方向，全面负责部门日常人员管理、质量和政策合规；
Coordination and cooperation with other functional departments.
各职能部门之间的协调与合作。
Job Requirements /岗位要求：
1、Education Background/学历背景:
At least PhD or MD degree, clinical medicine and biology background, excellent candidates can be appropriately relaxed;
具有临床医学及生物学背景，博士学历或医学博士，具有双学历更佳，优秀者可适当放宽；
2、Working Experience /工作经验：
At least 10 years of Clinical related experience, management experience is preferred;
工作经验10年及以上，有管理经验者优先；
3、Skills /能力要求：
Familiar with GCP and other relevant rules and regulations, have knowledge on drug development process;
掌握GCP等相关法律法规，了解药物研发过程；
Fluent English on both written and verbal;
英文口语和写作俱佳；
Excellent communication and influence skills.
沟通和影响能力俱佳。
4、Others/其他：
Deep understanding of Pharmaceutical Industry and rich clinical research knowledge;
深刻理解制药行业，临床研究知识丰富；
Highly sensitive to Business, and have strategic insight to promote new Business directions from translational medicine perspective;
高度的商业敏感性，具有从转化医学角度推动新业务方向的战略洞察力；
Cross-functional leadership;
跨职能领导力