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).
Cross- function teams in China R&D (e.g. RA, GCO, Statistics, Discovery, MA, Project management, PV, etc.)
Global compound development team
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
Qualifications
A. Education /Training background:
MD. is mandatory; MSc. or PhD is an asset.
B. Knowledge/Skills:
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
D. Competency:
Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities.
E. Others:
excellent english ablities of listening, speaking, reading and writing; same level of CET-6
Primary Location
China-Beijing-Beijing-
Organization
J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function
Clinical Research MD
Requisition ID
1905758778W
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