南京招聘

Position: Study Physician, Manager

Department: Clinical Development

Report to: Clinical Development Head

Location: Shanghai

About Connect Biopharmaceuticals

Connect Biopharmaceuticals is a China-based global clinical-stage company focused on discovery and development of novel immune modulators for the treatment of autoimmune diseases and inflammation.

Job introduction

Study Physicians design and ensure successful conduct of clinical studies with highest integrity in China and review study results. Study Physicians are core members in Product Clinical Development Team and responsible for compound's China development strategy and plan. Study Physicians are also responsible for supporting global team on compound global development strategy and global study conducting.

Major responsibilities

• China clinical development strategy and plan (including protocols) for responsible projects
• Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
• Co-owners of clinical study delivery (with Clinical Operations and Stats)
• Development documents (IB, protocol and CSR, etc) content owner
• Analysis and interpretation of clinical study results in partnership with Stats, Clinical Operations and Safety (as well as Clinical Pharmacologist if necessary)
• Forming and running China protocol review committee
• Forming and running advisory board for portfolio projects
• Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
• Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting including updating safety profile in the Investigator's Brochure, Risk Management Plan, DSUR, etc.
• Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
• Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction
• Be a TA clinical science expert and supporting China regulatory filing and registration
• Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project
• Oversight the delivery of CRO company and related vendors to ensure the study meet the timeline and ensure the quality
• Interfacing with CRO study teams and study related vendors on clinical sciences matters
• Providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators

• Summary
• A core function on Product Clinical Development Team representing TA Clinical Science
• Be the interface with Regulatory/KOLs/CROs on clinical sciences matters
• Provide clinical science support and training to internal team on needed base
• Liaise with BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds
• Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA

Requirements

• Medical Degree/Medical training, Physician License is a plus
• At least 3 years of clinical development experience (at least as clinical research physician for 1~2 years) in pharmaceutical and/or biotech industry or CRO company, clinical practice in TA is desirable
• Medical expertise in related therapeutic areas
• Good GCP knowledge and deep clinical trial related knowledge
• Experience of study design and drug development plan
• Regulatory guidance for the TA
• Experience of medical monitoring, safety reporting and Risk Management Plan
• Familiar with CSP/CSR content & data analysis
• Fluent English and Chinese, written and oral
• Good Presentation & communication skill
• Can work independently as well as a good team player
• Demonstrate the leadership in the cross function work and can adjust to the fast speed work
• Prioritize and focus with attentive to detail and excellent analytical skill
• Clinical practice in related TA, Stats knowledge, Investigator & site knowledge, Industry/competitor knowledge are highly desired

职位: 研究医生，经理

部门: 临床发展部门

汇报上级: 临床发展负责人

工作地点: 上海

公司简介

康乃德生物医药是立足于中国的，具有全球权益临床阶段产品的新药创新公司。康乃德专注于发现和开发新型免疫调节制剂，治疗自身免疫性疾病和炎症。

职位介绍

研究医生设计并确保在中国完成具有最高完整性的临床研究的成功进行，并审查研究结果。 研究医生是产品临床开发团队的核心成员，负责中国发展战略和计划。 研究医师还负责支持全球团队进行全球发展战略和全球研究指导。

主要职责

• 负责项目的中国临床发展战略和计划（包括协议）
• 确保所有范围内临床研究的成功实施和完整性（即提供医疗监测）
• 临床研究交付的共同负责人（临床操作和统计）
• 撰写文档（IB，协议和CSR等）内容负责人
• 与统计师，临床运营和药物安全（以及临床药理学家）合作分析和解释临床研究结果（如有必要）
• 组建并运行中国方案审查委员会
• 组建并运行管线项目咨询委员会
• 负责与中国KOL进行合作和交流，以开展中国发展战略和方案设计
• 与安全医师联络，对安全信息进行计划级别评估，评估安全信号，遵守安全报告的合规性，包括更新研究者手册，风险管理计划，DSUR等中的安全概况
• 与临床药理学家就PK / PD项目进行联络，确保成果可交付
• 在监管提交和沟通/合作中为解决医疗问题确定战略方向
• 作为治疗领域临床科学专家，支持中国监管机构的申报和注册
• 作为治疗邻域临床科学专家，与监管官员就某一项目的临床科学主题进行主要讨论
• 监督CRO公司及相关供应商的交付，确保研究符合时间表并确保质量
• 与CRO研究团队交流并研究相关供应商的临床科学问题
• 就方案设计问题向临床运营同事提供咨询，并回答现场调查员有关方案的问题
• 小结
• 代表治疗领域临床科学的产品临床开发团队的核心职能
• 成为与临床科学问题相关的法规/ KOL / CRO的接口
• 在需要的时候为内部团队提供临床科学支持和培训
• 与BD协作，以支持产品上市前的市场推广活动，出版物，会议和对化合物的早期市场进入
• 拥有最新的医疗/科学知识以及临床试验情况和竞争情报

任职要求

• 具有医学学位或受过医学培训，有医师执照优先考虑
• 在制药和/或生物技术行业或CRO公司至少有3年临床开发经验（至少作为临床研究医师1至2年），具有治疗邻域临床实践尤佳
• 具有相关治疗领域的医疗专业知识
• 良好的GCP知识和深入的临床试验相关知识
• 研究设计和药物开发计划的经验
• 技术援助的监管指导
• 医疗监测，安全报告和风险管理计划的经验
• 熟悉CSP / CSR内容和数据分析
• 流利的中英文书面和口头表达能力
• 良好的表达和沟通技巧
• 可以独立工作，也可以成为一名优秀的团队成员
• 展示跨职能工作的领导能力，并可以适应快速工作
• 优先考虑细节和出色的分析技巧
• 具有相关治疗邻域、统计知识，研究者和临床试验中心知识，行业/竞争对手知识等临床试验经验的尤佳

    苏州康乃德生物医药公司(简称“苏州康乃德”)由具有制药行业新药开发及国内外创业成功经验的海归博士团队于2012年初创建成立，公司毗邻上海的(苏州)太仓市生物医药产业园。
    苏州康乃德布局全球，致力于成为自身免疫疾病和炎症疾病领域创新药研制的全球引领者。
    康乃德作为立足生物医药高端制造领域的头部企业将积极带动地区产业集群和推动产业创新，与沙溪星药港、港区生物港产生联动效应，助推太仓生物医药跨越发展。
    康乃德当前拥有国际专利达46项，预计3年内可完成100＋项专利。
    康乃德将引进和培养生物医药领域的各类人才，倾力打造雇主品牌。

公司地址：
215400 中国，江苏省，太仓市，北京西路6号，研发东楼3楼
邮箱：syhu@connectpharm.com