北京招聘

-        The CSM was analyzing Chinese KOLs and different Universities/Hospitals in order to select our most important partners to start clinical activities. The CSM role was to elaborate topics with those KOLs to start series of collaborations such as IITs and a reference center. Clinical support was focused on IITs.

 

-        we expect to also run Geistlich studies in China for registration purposes. First with GFG for which we from HQ would prepare strategy and protocol, but for the conduct we need a local person with knowledge about clinical trials and who can find and assess necessary external partners (CROs) which we will need to have for a study appropriately run.

-        The CSM would then be a local coordinator of all clinical activities connected with such study and act as a local study director. It is not clear what would be the load of such clinical studies over the coming years, therefore KOL liaison, education activities, IITs are important to have enough load in this CSM function.

-        Support the recertification of all existing products in the Chinese market.

-        Support the registration of Geistlich Bio-Gide compressed and Geistlich Bio-Guide shape as a local study coordinator reporting to China RA.

-        Create a China-specific Clinical Science concept including projects, activities, milestones and priorities for success in the Chinese market.

-        Create a detailed concept for the Centers of Excellence including an active collaboration with and coaching of these centers

 

Current job description (clinical support) – focused only on IITs and MTAs:

 

-        Identify possible Investigators and Study Centers

-        Discuss possible IIT projects with KOL

-        Submit study applications with a project request form via KOL-IT-Tool and clarify open questions with the KOL.

-        Communicate the decision about the application to the KOL

-        Fix the IIT contract according to our process with the KOL

-        Act as the GPAG representative to execute and control the IIT contract

-        Send the "Scientific Project Report Form" (e.g. PHFB_05181009) to HQ before Dec 5th

-        Act as the IRB national contact person

-        Support study material logistics

-        Provide HQ biannually with update reports

-        Provide education about GCP

-        Initiate and use of Material Transfer Agreements (MTA) to support KOL and strengthen relationship or build up relationship

-        Be contact person for the Ethical Committee and provide study dependent management of the documentation for the Ethical Committee

-        Contact person for the relevant national competent authorities

-        Monitoring of project progress (project dependent)

 

Additional Clinical Affairs expectations for China - if Geistlich clinical studies will be run:

-        Experience in clinical trial management

-        Understanding of good clinical practice and local clinical regulations

-        Worked with clinical monitors (CRAs), data managers, statisticians

-        Natural science background and genuine interest in the dental field

-        Experience in working with clinical experts (KOLs)

-        Responsibilities of local study director (direct management of study start, conduct, closure) – list of detailed study director responsibilities can be separately given

 

Clinical Affairs ‘nice to haves’:

-        Experience in dental field, dentist education

-        Existing dental network

-        Experience in medical writing of protocols and reports

-        Monitoring experience

-        Existing CRO network

    盖思特利商贸（北京）是瑞士GeistlichPharma AG 在中国的一家独资子公司。我们专注于医疗器械行业里的高端生物材料产品。主要产品为骨粉和骨膜，用于口腔内种植体和颌面创伤。
    总公司是家族企业，已经有150多的历史，中国子公司于2008年成立。
    GeistlichPharma AG 是一个传统的家族制企业，总部位于瑞士。在长达150多年的企业发展史中，一直专注于可持续的，独立的，依靠挖掘自身潜力获得商业成功。这样的发展模式使得企业能够更为独立，自由的计划企业长远的发展，同时能够实施更为有效负责的新产品研发.

    公司主要由三个分支构成；盖氏生物材料，盖氏外科，盖氏制药。1986年Geistlich Bio-Oss的问世奠定了盖氏生物材料这一分支在公司的领导地位。GeistlichPharma AG一贯秉承以市场为导向，不断创新的发展思路。通过严谨的产品研发和临床研究，推出了一系列优质的口腔再生领域产品。在注重创新和研发的同时，GeistlichPharma AG的产品均严格遵照最高品质的生产标准。产品的“瑞士品质”能满足最挑剔顾客的要求。同时GeistlichPharma AG提供可靠的、高质量的服务，并为临床专家提供最新的临床治疗理念和技术。高品质的产品和服务是GeistlichPharma AG的最核心的市场理念。