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POSITION SUMMARY: 

The MRI Head is responsible for leading the medical team of Medical Research and Innovation, including study management, publication and scientist team to drive and lead the overall IEGP development aligned with medical strategy, and review/approval process including LCRC and ensure following processes (RECAP, APPRC, etc) are followed. Partner with Medical TA colleagues, R&D, PADU and cross teams to ensure study execution, and monitor the process against clinical research guidelines and safety procedures. Support medical research team members, providing inputs to study design, risk analysis and clinical consultation relative to therapeutic area. Work with cross functions to drive the high-quality publication plan and publication outputs and empower China MAF the publication-wise knowledge. Work with MA to assess study feasibilities and develop statistical analyses plan and TFL of approved CSS. Provide real world evidence and epidemiology advice to various stakeholders. Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites. Identify issues during the life time of IEGP, update SOPs if needed. Provide training to colleagues and increase the overall research capability of China MAF. Drive and lead MAF innovative projects according to the strategy.

PRINCIPAL RESPONSIBILITIES may include but no limited to:

• Lead the overall IEGP development aligned with medical strategy, and review/approval process including LCRC and ensure following processes (RECAP, APPRC, etc) are followed.
• Partner with Medical TA colleagues, R&D, PADU and cross teams to ensure study execution, and monitor the process against clinical research guidelines and safety procedures.
• Support medical research team members, providing inputs to study design, risk analysis and clinical consultation relative to therapeutic area.
• Work with cross functions to drive the high-quality publication plan and publication outputs and empower China MAF the publication-wise knowledge.
• Work with MA to assess study feasibilities and develop statistical analyses plan and TFL of approved CSS. Provide real world evidence and epidemiology advice to various stakeholders.
• Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
• Identify issues during the life time of IEGP, update SOPs if needed. Provide training to colleagues and increase the overall research capability of China MAF.
• Managing timely report of study progress and budget update with analysis for LT.
• Responsibility for developing successful, collaborative relationships with the AP/Global teams and relevant functions.
• Building efficient organization structure, leading and manage team providing training, supporting and coaching. Identify and develop key talents for the team growing.
• Drive and lead MAF innovative projects according to the strategy.

COMPETENCY REQUIREMENTS: 

• Candidate must possess a master’s degree or above of clinical medicine or pharmacy. M.D. and PhD preferred.
• Above 10 years of pharmaceutical industry experience overall.
• At least 5 years of Medical Affairs in a leading role with people management are required.
• Demonstrated ability in strategic thinking, scientific mindset, good planning & tracking and contingency planning with respect to pharmaceutical objectives.
• Strong oral and written communication skills
• Demonstrated influence, negotiation, team management, resource management and conflict resolution skills, including the ability to influence even without clear reporting authority.
• Budget planning and implementation skills are essential.
• Good problem-solving skills for developing creative solution.
• Integrity, compliance, reliable
• Domestic and International travels are required.

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