General job accountability:
Lead the clinical development of pipeline portfolio in relevant TA in China and/or globally (for some specific China R&D-driven compounds). Deeply understand global clinical development strategy and TA trend; Collaborate with various global and regional function teams to generally command academic direction of CD strategies in relevant TA. Lead cross-functional team to develop and drive TA CD strategy, programs/projects and ensure excellent implementation in China and/or globally. Communicate and cooperate with internal and external customers. Train and develop CD TA team.
Main Responsibility:
l Lead the clinical development of pipeline portfolio in relevant TA in China and/or globally (for some specific China R&D-driven compounds). Deeply understand global clinical development strategy and TA trend; Collaborate with various global and regional function teams to generally command academic direction of CD strategies in relevant TA.
l Lead cross-functional team to develop and drive TA CD strategy, programs/projects and ensure excellent implementation in China and/or globally for specific China R&D-driven compounds; develop and/or approve clinical study design, study documents, clinical dossier, and guide publication plan. Guide and/or implement medical tasks and activities during the conduction of clinical study (including medical monitor, etc.) to ensure the medical and scientific sound of the CD programs. Ensure the CD strategy fulfill HA requirements for compound registration.
l Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders.
l Train and develop CD TA team. 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.
Requirement:
Education /Training background:
l MD. is mandatory; MSc. or PhD is an asset.
Knowledge/Skills:
l Thoroughly understand and command knowledge of product and relevant diseases
l Solid knowledge of clinical development process and HA (especially SFDA) requirements
l Thoroughly understand and command GCP
l Thoroughly understand and command HCC
Job experience:
l At least 7-year clinical practice in relevant therapeutic area/or 5-year working experience in pharmaceutical industry (especially clinical development, and people management) is preferred
Competency:
l Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities.
Others:
l excellent english ablities of listening, speaking, reading and writing; same level of CET-6
Anyone who interested in the position, pls send your cv to annietan@allegisbn.com.
发表于 2011-12-14 13:00:28
