· Lead the clinical development for the assigned compounds or products in China and/or globally (for some specific China R&D-driven compounds).
· Deeply understand global clinical development strategy and plan. Lead cross-functional team to development and drive CD plan and ensure the clinical development plan fully aligned for China and globally (for some specific China R&D driven compounds). Keep the China clinical development plan updated. Be responsible for the clinical project planning.
· Propose clinical study design and develop clinical study protocol based on the clinical development plan, Be accountable for all clinical deliverables (e.g. clinical study reports and submission summary / HA response document) if applicable. Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. Act as compound medical physician for some specific China R&D-driven compounds. Provide physician guidance and expertise on patient care to clinical studies (including medical monitor, etc).
· Provide clinical input for commercial assessment and portfolio prioritization. Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders. Undertake tasks as agreed with the TA head.
· Train and develop team if applicable. Provide hands-on coaching and guidance to team members; identify talent and create talent development and retention plan and ensure the plan is well executed.
· Lead the development of CD strategy and plan based on the registration strategy, and ensure excellent implementation.
· Be accountable for all clinical deliverables (e.g., Clinical study protocol, clinical study reports and submission summary / HA response document) if applicable
· Act as clinical expert concerning the clinical scientific issues from internal customers.
· Answer expert advice on the compound or product under active development
· Communicate and obtain alignment of CD strategy and clinical program plans in China for the compound
· Communicate and obtain alignment between CD strategy and marketing strategy for pre-marketed compounds
· Provide clinical input for the commercial assessment
· Understanding global trend of the product and coordinating regional product designing plan
· Closely collaborate with KOLs and maintain academic relationship with them
· MD. is mandatory; MSc. or PhD is an asset.
· Thoroughly understand and command knowledge of product and relevant diseases
· Solid knowledge of clinical development process and HA (especially SFDA) requirements
· Thoroughly understand and command GCP
· Thoroughly understand and command HCC
· At least 3-year clinical practice in relevant therapeutic area/or 5-year working experience in pharmaceutical industry (especially clinical development, and people management) is preferred
· Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities.
· Excellent English abilities of listening, speaking, reading and writing; same level of CET-6
J&J (China) Investments Ltd (7046)