1 Clinical Development Operational Activity

• Manage all assigned clinical programs run
locally in China, or in support of the global studies being run in China to
ensure clinical studies are effectively managed.

• Work closely with all areas across
Clinical Development to leverage the scale and operating model of the global
organization (e.g., governance, ESP selection and oversight).

• Actively manage organizational
effectiveness and address challenges that are impeding operational delivery.

• Provide expertise and guidance to global
teams for operational execution and to allow the most compliant and efficient
filing with the CDTA and appropriate regulatory agencies.

• Continually assess operating procedures
and take action to drive on-going quality improvement. Align best practices with
the global CDO organization.

2 Strategic Planning

• Provide operational input into local and
global Clinical Development Plans, including best approaches for Chinese site
and patient recruitment; ensuring expectations for local regulations are met;
and aligning with global objectives, timelines and budget.

• Provide feasibility assessments for study
conduct in Chinese sites

3Financial & Resource Management

• Develop and manage China clinical trial
services budget to ensure strategic spending with External Service Providers.

• Efficiently use internal resources as
well as accurate forecasting across the Clinical Development portfolio of China
studies. Provide input to the global studies, as appropriate.

• Ensure assigned Clinical Programs are
adequately resourced and lead the prioritization of work and resources across
Clinical Programs in China.

• Create and optimize a scalable resourcing
strategy to support seamless delivery of clinical studies with a combination of
internal and external resources.

4 Quality Operations

• Ensure all areas of accountability are
compliant with procedural requirements; ICH/GCP guidelines; C-GCP-like; and
other local and national regulatory standards and requirements.

• Ensure China Clinical Development
Operations input into investigations and followupactivities for all clinical
CAPAs involving clinical programs run locally in China and global studies being
run in China.

• Ensure coordinated relationship with CQCC
and CQA to drive inspection readiness and overall quality of clinical studies.

5 External Relationship Development

• Manage strategic vendor relationships to
ensure consistent delivery of contracted services through direct communication
with key vendor’s executive management.

• Drive continuous improvement, cost
savings and innovation in local CRO relationships. Oversee active governance
for CRO relationships.

• Manage overall approach for cultivating
relationships with KOLs and study sites in China to enable company to be
sponsor of choice for clinical development