Clinical Development Scientist

In this role, you have the opportunity to

• Provide 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 & LCM
• Participate in the CDMA(Clinical Development and Market Access) process
• Participate in the development of clinical deliverables, including clinical evaluation reports, clinical trial protocols, CSRs & clinical sections of regulatory submissions
• Working closely with Clin Ops and BS&DM on day to day management of assigned clinical studies
• Supports 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.