• Act as the MM for assigned projects and deliver on everything related and needing medical expertise and input
• Develop and execute phase 1,2,3,4 clinical strategies and plans that deliver medically differentiated therapies that provide meaningful improvement to patients
• Develop clinical development strategy, plan, ensure effective and efficient execution for the assigned projects, RFPs, BDMs, and other tasks
• Participate in CDE/HA/RA interactions or others
• Prepare slides for medical considerations for RFPs and all assigned projects and tasks
• Prepare MMPs, and finalize internally and also align with sponsor and finalize with signature and appropriate filing
• Accountable for all trainings related to medical science, protocol, disease target/drug/MOA of sponsor and any epidemiology data analysis presented in slide format and all clinical trials landscape evaluation/presentation
• Studies data interpretation and explanation to internal study team/CRA/PM and sponsor study teams
• Participate in ongoing development/enhancement of processes, structures, organization chart, services overview, systems, tools and other resources, as appropriate
• As needed, could assist manager or department in recruitment, interview, coaching or new or any staff or colleagues
• Stay abreast and be up to date to the latest development trends, market dynamics, at all times, and know the implications to new/on going or future projects
• Competitive intelligence, market/industry assessment and interpretation
• Maintain the highest standards and level of scientific/medical and clinical knowledge in therapeutic and disease are assigned
• Should collaborate and be flexible with all internal/external partners/stakeholders/colleagues
• Participate in meetings, reviews, discussions, interactions regarding medical science and medical affairs, for input, guidance, recommendation or suggestion with rationale, justification and evidence whenever available, including meeting with health authority ethically, professionally and effectively
• Support MW, DM, stats or others in publication process and information input
• Might support in partnering, joint venture, integration, strategic partnership, license-in/out from identification, assessment, and any process related that might need help
• May participate, prepare, present at DSMB or other meetings
• Develop TTP, CDP, etc… or as required support any submission/or regulatory/publication documents, data strategy, KOLs development plan, publication plan, IIT development, EAP development
• Responsible for strategic and operational execution as agreed in meetings
• Ensure high productivity and efficient delivery of all assigned task in a timely delay without affecting quality and deadlines
• Seek guidance from manager as and when needed and escalate matters in a timely manner and as needed
• Responsible for clinical oversight of all ongoing studies assigned
• Responsible for design, safety assessment, medical coding, queries resolution, clinical sections of IB, presentations, selection/feasibility of investigators/sites/research centers, patient registry design/implementation, support on DM plan, ongoing review of medical/safety data, review and identify variances in data and resolve, finalize IA, development and implementation of communication plan as needed, data generation
• Responsible for CD plans, objectives, deliverables are all accomplished on time and on target
• Lead and complete special projects assigned by manager
• Comply with all corporate policies, SOPs, etc….

其他信息
语言要求：英语、普通话

所属部门：Medical Affairs