Clinical Development Head - BioPharma

Biopharma Clinical Development Head is a SET-2 role and take the overall accountability to the Head of R&D China for biopharma portfolio delivery and safety science in China, including development of scientific strategy, creation and implementation of Clinical Development Plans of Biopharmaceutical therapeutic area. The role is an important interface representing R&D China with internal and external stakeholders in the responsible TA. The role also has line management responsibility for development physicians/scientists in Biopharmaceutical TA. This role will also serve as the co-chair of Project Review Forum of biopharma TA and member of China Portfolio Management Committee.

Typical Accountabilities

• Lead to develop China Biopharma drug development strategy, and contribute to R&D China scientific strategy
• Responsible for planning and execution of all biopharma portfolio projects, serve as a member of China portfolio management committee (PMC) for biopharma TA decision making
• Accountable for the successful delivery of biopharma portfolio, co-chair China Biopharma Project Review Form to ensure the quality and speedy delivery
• Owner of development documents (CIB, protocol and CSR, ETC) with China content
• Oversight of Safety and PK/PD programs at portfolio level to support the portfolio project delivery
• Oversee TA clinical science, Translational medicine and Safe science functions, drive the performance for project delivery and any other initiatives
• Build and develop a strong Biopharma clinical development team, foster a life-learning culture, coaching culture, develop physicians’ capability, and support their career development
• Build and develop strong CNPT (China Product Team) in biopharma TA
• Lead to ensure effective collaboration with global biopharma clinical development teams, to foster knowledge sharing, global projects deliver and talent exchange
• Build and strengthen the alliance with key external partners including the academia institutes, and KOLs
  
  

• Medical Doctor Degree
• Global drug development experience
  
  

• Deep biopharma therapeutic area knowledge
• Sufficient regulatory knowledge for BioPharma TA and necessary Statistics knowledge
• Insight on biopharma research and development in China
• Broad network with Chinese KOLs and investigators
• Deep knowledge of CSP/CSR development and study data interpretation
• Excellent in communication and presentation, both in English and Chinese
• Strategic thinking and prioritization
• Strong problem solving and analytical skills
• Strong leadership in building effective teams, developing talents, etc
• Ability in fostering collaboration, life learning, inclusion & diversity cultures
  
  

• Minimum 10 years clinical development experience in pharmaceutical companies
• Minimum 5 years on biopharma TA leader role (>= Director level position) with successful delivery track record of drug development and registration
• Rich NDA submission experience
• Rich Medical monitoring experience
  
  

• Experience in regulatory agency interaction
• Philosophy Doctor degree