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Clinical Science Lead


Shanghai, Shanghai, China

Job Function:  Clinical Development
Job ID:  64102

For the assigned program/project(s) in the region with minimum support by function head / seniors:

  1. Assume overall responsibilities as a country (also regional if applicable) level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work.
  2. Drive the development of Clinical Development Plan (CDP) and relevant study designs through team effort; ensure input from internal or external expertise is integrated and reflected in the CDP. Such expertise may include but not limited to key opinion leaders, global Patient Value Unit, regulatory affairs experts, project/study physicians, project management, biostatisticians, and pharmacologists.
  3. Be responsible for overall implementation of the CDP to ensure timelines, budget as well as deliverables are within expectation.
  4. Co-author and/or review protocol concept / protocol, other study-related clinical documents according to the CDP, and scientific publications.
  5. Ensure that medical science is well incorporated into the clinical development strategy, plans and study designs.
  6. Guide the team through data analyses and review to conclude for study result interpretation.
  7. Serve as the leader in logic construction in clinical for various submissions across the region, such as CTD/eCTDs, CTAs/CTNs and NDAs or IDLs.
  8. Contribute to establish “Center of Excellence” in clinical development in China and Asia.
    9) Oversight CRO's medical monitoring activities and educate medical monitors

10) Contribute to safety evaluations to ensure participating patients’ safety in clinical studies.

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