南京招聘

Head of Clinical operation (Director Level) (Salary/Compensation package based on qualifications/experiences)
Base: Open
Roles & Responsibilities:
1) Be the point person and leader for Connect’s clinical operation and be accountable for ensuring the delivery of high quality clinical trial data
2) Participate in establishment of Connect’s clinical development strategy; Translate the strategy into executable action plans and establish priorities in line with company goals and priorities
3) Coordinate and participate the IND package preparation, facilitate and support IND submission
4) Establish and lead internal clinical/medical operation team/system; Coordinate Clinical Research sites and Manage Clinical CRO team(s), and other roles as relevant
5) Be responsible for ensuring execution of clinical trials. Proactively identify key issues in clinical trial execution, propose appropriate solutions and organize follow-up resolving implementation, ensuring compliance with ICH/GCP and local authorities guidelines
6) Build effective working relationships with regulatory bodies, as well as KOLs/PIs; and organize communication in a timely manner with CFDA/FDA (e.g. end of phase II meeting and etc.), and handle inspections by external bodies including regulatory authorities
7) Be responsible for clinical program team budget and operating expenses
8) Frequent domestic (and occasionally International) travel required

Education/Qualifications:
1) An undergraduate or above degree in life sciences or health-related field from an accredited institution or its international equivalent preferred
2) Thorough knowledge of ICH and local regulatory authority regulations is a must and a minimal of 8 years clinical development/operation experiences in China is required, CRA/CRC China experiences is a plus
3) Excellent organization and coordination and interpersonal communication skills, Direct supervisory experience with a successful track record of mentoring junior staff is preferred
4) Highly motivated self-starter, enjoy working both independently and collaboratively in a fast-paced team environment. Capable of working under pressure and willing to travel frequently
5) Adequate experience using computerized information systems including MS Office software is required. Proficient in Chinese and English

临床研究运营负责人 (总监级别) (薪资福利待遇根据经验、资历和能力等情况商议)
工作地点：北京、上海
主要职责
1) 作为临床运营的负责人，领导公司临床运营团队、并对确保提供高质量的临床试验数据负责
2) 参与建立公司的新药项目临床发展战略，并负责将战略转化为可执行的行动实施计划，并根据公司的目标和优先计划来制定新药项目临床运营中的优先事项
3) 组织、协调和参与临床申报材料的收集汇编，并支持和推动临床申报工作
4) 建立内部临床/医疗运营系统，带领公司临床运营团队协调临床研究中心并管理好相关临床CRO团队，做好其他相关工作
5) 负责确保临床试验的执行。主动发现临床试验执行中出现的关键问题，及时提出相应的解决方案并组织实施跟进解决，确保临床运营遵循和符合ICH/GCP和各相关国家及区域地方当局的法律法规政策
6) 与监管机构以及临床意见领袖/关键临床研究者建立有效的工作关系，并与CFDA / FDA及时组织相关沟通(如临床二期结束讨论会议等)，以及应对好监管部门和外部机构相关检查工作
7) 负责临床项目团队的预算和临床运营费用成本控制
8) 需要经常旅行(包括国内、国际范围)出差

资格要求：
1) 生物医药、医学相关本科或同等学历以上文化程度，临床药学、临床医学或国外相关学历资格更佳
2) 对ICH、FDA/CFDA等医药行业相关的法律法规有透彻的了解，至少8年以上新药项目临床研究协调、运营及管理经验，具有参与新药项目临床I/II/III期研究全程经验者优先考虑录用，有CRA、CRC工作经验的更好
3) 优秀的组织协调及人际交流能力，具有带领团队、直接培养初级员工成功经验者优先录用
4) 良好的自我激励素质及上进心，能独立工作同时善于以快节奏推动有效协作，能经常出差、同时必须具备有良好的抗压能力
5) 熟悉OFFICE系列办公软件(PowerPoint, project及excel等)及使用计算机信息系统，包括办公自动化软件；精通中英文。

    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