(Senior/Principal) 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.