Sr. Physician
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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. |
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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). |
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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. |
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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. |
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B. Contacts of key internal
and external stakeholders： |
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Internal |
Objective |
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Cross-
function teams in China R&D (e.g.
RA, GCO, Statistics, Discovery,
MA, Project management, PV, etc.) Global compound
development team Strategic marketing/marketing team Regional/global TA person in charge External |
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 |