Job TitleClinical Development Scientist

Job DescriptionJob DescriptionIn this role, you have the opportunity toProvide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;Lead the clinical evaluation projects across the product lines, work closely with Regulatory team, product team, marketing team to develop robust and rational clinical evaluation strategy; Ensure the clinical evaluation projects successfully accomplished on time and on quality;As key scientific reviewer to assess the scientific and ethical of the company sponsor study & IIS;

You are responsible for

Participate in the evidence generation processes for NPI & LCMParticipate in the CDMA(Clinical Development and Market Access) processParticipate in the development of clinical deliverables, including clinical evaluation reports, clinical trial protocols, CSRs & clinical sections of regulatory submissionsWorking closely with Clin Ops and BS&DM on day to day management of assigned clinical studiesSupports clinical literature searches and reviews

To succeed in this role, you should have the following skills and experience

Education: Master or PhD in Biomedical Engineering or medicine.

Experience: 3 years’ experience in clinical development function or related clinical area.

Competencies and Skills:

Demonstrated expertise in NMPA regulatory requirements and clinical data interpretation;Effective organizing, communication, and project management skills;Effective verbal and written skills in both English and Mandarin;Proficient in Biostatistics software is preferred.