Clinical Research Head

面议

上海市

刷新时间：2021-01-22

职位描述

Primary Function 主要职能：

Deeply understand pipeline and strategy. To develop, drive and oversight the implementation of therapeutic area strategy and portfolio management. Collaborate with different cross-functional team to generally command academic direction of R&D strategies for medical products.

深入理解产品管线和发展策略。开发、推动和整体管控治疗领域的发展策略和项目组合管理策略的实施。与不同职能部门合作全面掌控医疗产品的研发方向。

Major Responsibilities and Duties 主要职责和任务 :

1. Deeply understand Therapeutic Area strategy and trend. Ensure drug development plan is in line with TA/portfolio strategies.

深刻了解公司的治疗领域策略和趋势。确保药物开发策略符合研究领域/项目组合策略。

2. Ensure to obtain Global perspective view to improve TA development.

确保应用全球化的视角促进TA的发展。

3. Make sure the medical product development strategy is fully and timely aligned with and endorsed by the key stakeholders.

确保产品发展策略完全及时的与主要利益相关者保持一致并得到其认可。

4. Co-drive the new compound “Go/No Go” proposal and propose compound team formation.

联合推动新药研发的“Go/No Go”提案，并提出团队组建策略。

5. Lead Medical/Clinical Research team to

- Ensure the clinical development plan fulfills requirements for registration. Responsible for clinical study design, developing study documents, clinical dossier, and guiding publication plan.

- Guide and/or implement clinical tasks and activities during the conduction of clinical study (including medical monitor, etc.) to ensure clinically and scientifically sound of the clinical development strategy and development plan.

- Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders.

带领医学临床研发部门：

- 确保临床开发计划符合公司的药品注册要求。负责临床试验设计、临床研究文件和发表计划。

- 在临床研究的实施过程中主导和/或提供医学相关支持以及活动，确保临床开发策略和开发

- 与内外部客户的合作交流，与专家和关键利益人员建立和维护紧密的学术关系和合作关系。

6. Establish Medical/Clinical Research team. Provide hands-on training, coaching and guidance to team members; acquire and identify talent and create talent development and retention plan and ensure the plan is well executed.

组建医学临床研发团队，为团队成员提供培训，辅导和指导；识别并引进人才，建立人才发展和保留计划，并执行该计划。

7. Contact with key internal and external stakeholders, such as cross-functional teams in R&D (e.g. RA, Statistics, Discovery, PMO, Clinical Operations etc.), external KOL, specialized medical association and other key stakeholders.

与内外部相关团体维持联系，如R&D内部的其他职能部门(RA，分析和药物发现部，PMO，临床运营等)，外部专家，专业医学学会和其他相关人员。

Qualifications 资格要求:

1. MD. is mandatory.

临床医学专业。

2. Thoroughly understand and command knowledge of product and relevant diseases.

对药物开发和相关疾病具有透彻的认识。

3. Solid knowledge of new drug development and clinical development process and HA (especially NMPA) requirements.

熟知新药开发，临床发展过程和监管部门(特别是 NMPA)的管理规定。

4. Thoroughly understand and command Healthcare compliance (HCC).

熟知HCC的各项规定。

5. At least 5-year clinical practice in relevant therapeutic area and 10-year working experience in pharmaceutical industry (especially clinical development, and people management).

至少五年在相关治疗领域的临床实践经验，10年药企工作经验 (特别是临床发展，和人员管理 )。

6. Strategic and creative thinking capabilities; keen on clinical development insight; excellent communication and team collaboration skills; leadership capabilities.

具有创新和战略思维能力，敏锐的临床发展视角，优秀的沟通能力和团队合作能力，卓越的领导力 。

7. Excellent English abilities of listening, speaking, reading and writing; same level of CET-6.

优秀的英文听说读写能力，或CET-6 同等水平。

8. Strong written and spoken communication skills.

优秀的沟通技巧。

其他要求

招聘人数：10人
职能类别：临床总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。