岗位职责:

1.Work as China Working Group (CNWG) lead to drive the planning and execution of projects

This individual takes a leader role to lead and drive China project moving forward in DSCN, and ensure the successful deliverables.

This individual works closely with PM to facilitate the good cross-functional collaboration in DSCN towards the planning and execution of the project

This individual manages a good interaction with global key stakeholders, and represents CNWG to seek global governance body's endorsement on DSCN's proposal when needed


2.Develop China development strategy and China clinical development plan for new project and new indication.

This individual is responsible for developing the China development strategy and clinical development plan.

This individual collaborates closely with internal key stakeholders such as regulatory affairs, project management, clinical operation, BDM, medical affair and marketing, etc.

This individual serves as the key interface between Global Clinical Strategy Team (CST) and DSCN clinical development, and represents the China clinical development in CST as needed.


3. Create/Revise protocol and CSR

Whenever to conduct a local clinical study in China, this individual drives study design, and collaborates with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol/report. For China join in MRCT, this individuals provides China specific information to support global study protocol development/amendment, and develop a high quality China subgroup CSR if applicable.


4. Provide medical inputs for IND/NDA submission and HA consultation

This individual collects and consolidates the medical information (epidemiological information, treatment algorithms, competitive products, etc.) in China in order to prepare the IND/NDA submission and HA consultation related documents.

This individual provides medical input and reviews the IND/NDA submission and HA consultation related documents from China development perspective.

This individual addresses medical related issues/questions raised by HA and provides feedback to them.


5. Work as medical monitor to ensure the high quality of study execution

This individual works with CRO to supervise the study conduct in China from medical perspective.

This individual oversights the accumulating study data, evaluates the findings, and takes action as appropriate.


6. Connect and engage with KEEs and investigators at project and study level

This individual engages scientific leaders (KEEs) and introduces new compounds in development to China KEEs and seek feedback for our clinical development plan as needed.

This individual closely communicate with investigators from scientific perspective (e.g. Steering Committee) at study level.


7. Coach and guide team members to achieve the key deliverables (applicable for people manager)

This individual monitors, coaches and develops the leadership internally, to keep good collaboration within the team, and achieve the goal of the section.

This individual manages performance and develops talent through effective communication, cooperation, creative thinking, training, motivation, and evaluation, etc.

 

资历要求:


  1. Clinical medicine with master degree or above, or has at least 3 years physician experience
  2. Industry experience in oncology clinical development in hematological disease area and hematology background is preferred

  3. Hematology clinical work experience in hospital is preferred.

  4. At least 8 years working experience in ONC with more than 5 years experience in clinical development
  5. Solid experience of medical monitoring, IND and NDA submission
  6. Excellent language skills in both English and Chinese (fluent in verbal and written)
  7. Good collaboration with cross functional team
  8. Strong capability of work prioritization and deliver results with parallel multiple tasks
  9. Accountable, dedicated, persistent, and flexible
  10. Good command of computer