南京招聘

Position: Director of Clinical Operations

Department: Clinical development

Report to: CEO

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

In this position, the Clinical Operations Director is responsible for leading and manage the clinical operation team and provides leadership, strategic direction and oversight for all study, people and stakeholder management activities conducted by his/her team. The Clinical Operations Director will ensure clinical trials conducted in China within defined budget and timeline. He/she will lead the process of vendor selection and contract negotiation. The Clinical Operations Director is responsible to ensure that all the operational activities to have good adherence to ICH-GCP, Chinese legal/regulatory requirements and Connect's policies and SOPs.

Major responsibilities

1. Strategic Direction:

• Develops the strategy and drives implementation of tactics for Clinical Operations to meet both long-term and annual goals of the company.
• Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.

- Oversee the initiation and conduct of clinical trials by CROs ensuring timely recruitment and finalization.

- Manage suitable third party for out-sourced services (such as clinical research organization, central laboratories, data management, statistical analysis) necessary for the operation of clinical trial.

- Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, Connect’s SOPs and other relevant clinical research guidelines.

• Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team.
• Accountable for ensuring clinical operation budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensures adherence to budget forecasts.

2. People Management:

• Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.
• Accountable for resource management, performance management and career development of Clinical Operations staff.

3. Stakeholder Management:

• Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with company policies and country legislation.
• Develops and maintains excellent relationships and interactions between the Clinical Operations team, Medical team, safety, and other functions.

Requirements

• Master degree in medicine, pharmacy or other life sciences, MD/Ph.D. is a plus.
• Minimal 5 years of international pharmaceutical industry experience in clinical study planning, execution activities as senior manager/director of clinical operations.
• Good leadership skills and can inspiring other people
• Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations
• Fluent in both English and Chinese
• Good communication and interpersonal skills - works well with others, motivates and encourages
• Proficiency in computer skills, CTMS
• The ideal candidate is required to have experiences in clinical operations in multi-national companies. Previous Experiences in involving global or regional trials are preferable.
• Availability to travel nationally and internationally

职位: 临床运营总监

部门: 临床开发

汇报上级: 首席执行官

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

临床运营总监负责领导和管理临床运营团队，领导、战略指导和监督他/她所在团队执行的所有研究，人员和利益相关者管理活动。临床运营总监将确保在规定的预算和时间表内在中国进行临床试验。 他/她将领导供应商选择和合同谈判过程。 临床运营总监负责确保所有业务活动均符合ICH-GCP，中国法律/监管要求以及康乃德的政策和SOP。

主要职责

1. 战略方向:

• 制定战略并推动临床运营战略的实施，以实现公司的长期和年度目标。
• 积极采取措施确保临床研究的有效开展，包括按照开发管线所要求的，为开展现有和新的治疗领域的研究做好准备。

- 监督CRO临床试验的启动和进行，确保及时招募和入组完成。

- 管理为临床试验运行提供所需的外包服务的第三方（如临床研究机构，中心实验室，数据管理，统计分析）。

- 根据中国临床试验管理规范（cGCP）和ICH-GCP，康乃德的SOP和其他相关临床研究指南，组织、启动、监督和管理临床试验。

• 确定并实施战略战术以确保持续的生产力和效率提升，和高绩效的临床运营团队。
• 负责确保制定的临床运营预算准确并及时提交给部门预算讨论。 确保遵守预算预测。

2. 人员管理:

• 通过有效的领导、指导和人员管理，培养一支士气高昂的团队，以确保目标和业绩为导向的管理文化。
• 负责临床运营人员的资源管理，绩效管理和职业发展。

3. 利益相关者管理:

• 根据公司政策和国家立法，确保直接或间接与研究人员、伦理委员会、临床研究网络、患者团体以及当地卫生局的有效协作。
• 发展和保持临床运营团队与医学团队、药物安全以及其他部门之间良好的关系和互动。

任职要求

• 医学、药学或其他生命科学硕士学位，MD/Ph.D.优先考虑。
• 作为临床运营高级经理/总监，至少5年国际制药行业在临床研究计划、执行方面的经验。
• 优秀的领导能力，能激励他人
• 对药物开发过程、临床试验方法、中国法规环境、ICH/GCP指南和国际法规有很强的洞察力
• 流利的英语和汉语能力
• 良好的沟通和人际交往能力—与他人合作，激励和鼓励
• 熟练掌握计算机技能，临床研究管理系统
• 理想的候选人需要有跨国公司的临床运营经验。有参与全球或区域试验经验者优先。
• 可以国内和国际旅行

    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