1、Bachelors Degree in life sciences required
2、Advanced medical/Science Degree is preferred.
3、Advanced clinical trial experience (sound clinical trial experience in pharma/biotech industry)
4、Experience working on a clinical team (or equivalent)
5、Experience authoring aspects of clinical development plan or full clinical study protocol
6、Relevant therapeutic area experience
7、Has extensive knowledge of clinical research and has successfully worked across Phase I – III drug development projects
8、Well-versed in medical aspects of GCP (Good Clinical Practice), ICH, CFDA.
9、Excellent communication skills
10、Excellent presentation skills
11、Good computer skills
• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, and KOLs, as well as multidisciplinary internal groups, including research, business development, legal, etc.
• Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)
• Develops the CD plan with the Medical Director/AD for assigned molecule(s)/indication(s) and/or other programs Gathers and analyzes data and information necessary to create the CD plan.
• Where applicable and assigned, supports Medical Director/AD in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan
• Provides strategic clinical science support for assigned studies and programs:
1)Develops clinical study designs for review and discussion with Medical Director/AD.
2)Conducts appropriate literature searches.
3)Collaborates with clinical operations, other groups and Medical Director/AD/Principle CRP/Senior CRP to develop Informed Consent Form (ICF), protocol, Case Report Forms (CRFs), CRF instructions, etc.
4)Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Hutchison groups.
5)As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
6)Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Director/AD/Principle CRP/Senior CRP (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
7)Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs
8)As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings
9)Provides additional support with site training, as needed, or requested
10)Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
11)Collaborates with Medical Director/AD/Principle CRP/Senior CRP, clinical operations, data management and other groups to conduct medical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with Medical Director/AD/Principle CRP/Senior CRP, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
12)Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure