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Clinical Research Director

Responsibilities

Design and write up clinical trial and statistics plans for IND filing including phase I, II, III trials

  • Communicate with customers, clinical CROs and medical KOLs to assist in the implementation of clinical trials
  • Participate or organize activities related to medical affairs or clinical trials within and outside of the company
  • Write up and review medical paperwork of R&D programs
  • Proactively contribute to liaison and relationship with relevant authorities (cFDA),  industrial associations and research institutes
  • Retrieve and follow up the latest drug discovery regulations issued by FDA/cFDA and advancements of medical field
  • Recruit and train junior medical staff
  • Ensure team compliance on IP protection, safety, environment and company regulations
  • Complete other works assigned by leader

Basic Qualifications:

  • Master degree/or equivalent in a Medical or pharmacological discipline with 5 years work experience in clinical trial designing/writing
  • Experience with IND filing in pharmaceutical company is preferred
  • Familiar with ICH-GCP principles and clinical project management
  • Demonstrated ability to think strategically, design and direct original research, draw sound conclusions and effective communication to peers

Any applications,pls contact:liu_yuxian@wuxiapptec.com;global_talent@wuxiapptec.com