Clinical Research Physician

MAJOR RESPONSIBILITIES：

• Provide medical monitoring and medical leadership for clinical studies.
• Participate in development of Clinical Development (CD) strategy and plan, and support the assigned Medical Director/AD with CD plan execution.
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s), staying abreast of internal and external developments and trends.
• Collaborate with internal and external partners including clinical investigators, KOLs, research, business development, legal, and other multidisciplinary groups.
• Develop the CD plan with Medical Director/AD for assigned molecule(s)/indication(s), gathering and analyzing necessary data and information.
• Support Medical Director/AD in providing budget/resource requirements necessary to implement and execute the CD plan.
• Supervise, develop and mentor Associate CRP/CRP as assigned by clinical project leader.
• Develop clinical study designs and conduct appropriate literature searches for review with Medical Director/AD.
• Collaborate with clinical operations to develop protocol, ICF, CRFs, CRF instructions, and other study documents.
• Review safety narratives, safety-related guidelines, and provide clinical science input into documentation.
• Develop presentation materials for internal/external meetings, including investigator meetings, site training, and study communications.
• Act as primary CD liaison/point-of-contact for medical monitor inquiries from clinical operations, CROs, etc.
• Conduct medical review of study data, identifying and evaluating data trends, outliers, and protocol violators.
• Track protocol/ICF amendments and assist in responding to Health Authority (HA) inquiries.
• Write/review abstracts, posters, scientific meeting content, and support regulatory filing submissions including clinical science sections of HA meeting packages.

Qualifications/资质

• Bachelors Degree in life sciences required.
• Advanced medical/Science Degree is preferred.
• Advanced clinical trial experience (sound clinical trial experience in pharma/biotech industry).
• Experience working on a clinical team (or equivalent) .
• Experience authoring aspects of clinical development plan or full clinical study protocol .
• Relevant therapeutic area experience .
• Has extensive knowledge of clinical research and has successfully worked across Phase I – III drug development projects .
• Well-versed in medical aspects of GCP (Good Clinical Practice), ICH, CFDA.
• Excellent communication skills.
• Excellent presentation skills.