Director, Clinical Research Department
猎头职位 Full Time
2019-05-20 发布 工作地-Anywhere
Major Tasks and Responsibilities:
Provide opinions on long term strategic planning based on the company’s overall strategy and objectives.
Align with Headquarter and/or the study team for successful implementation of studies.
Lead the study team in China to develop a cross-functional and integrated study plan. Lead site selection and site qualification discussion, study team meetings such as kick-off meetings in China.
Develop relations with Key opinion leaders in the therapeutic area, visit and communicate with them regularly to play a key role in establishing a library of experts and smooth registration process.
Provide input into CRO selection, review study feasibility assessment and study implementation plan provided by CRO. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work and budget, so both can be managed appropriately.
Oversee the CRO to ensure that the study is executed according to the agreed project plan and to ensure compliance. Actively assess potential risks to the study and propose mitigation plans, if needed. Analyse CRO performance within a clinical study or across several studies and resolve or escalate accordingly.
Participate in and lead the audit by internal or external functions and inspection by authorities.
Responsible for resource management in China. Management requires review of resources against development pipeline in China to identify areas of resource gap, which includes appropriate use of DS employees and vendors to ensure adequate staffing.
Supervise direct reports which includes providing instruction of daily activities, coaching and guiding in support of their development needs, and facilitate conflict resolution on their behalf.
Qualifications:
Master Degree and above majored in Medicine, Pharmacy or related, Physician license or Doctor is preferred
Ten years’ experience in Clinical Research, three years’ experience in managing foreign-funded Clinic Department in Medicine and Pharmacy Industry