ACCOUNTABILITIES:

Accountable for the overall strategies and performance of the US study, response for planning and operational strategy and execution for assigned clinical trials

During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place

Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly

Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with internal departments to ensure on a regular basis that budgets, enrollment, and gaiting are accurate

Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted, if needed;

Confirm adherence to GCP compliance execution through all stages of clinical trial conduct including but not limited to: core study execution documents, clinical trial sponsor oversight, deviation management and internal audit support

Managing all aspects of study progress from start-up to close-out activities and assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.

Qualifications：

Bachelor’s degree in biological science, nursing, or pharmacy (or equivalent) as a minimum. Advanced degree preferred.

Minimum 15 years of experience in the pharmaceutical industry in a position performing clinical operations functions, at least 5 years as Clinical Head.

Must be a demonstrated self-starter and team player with strong interpersonal skills

Results oriented, able to use a variety of resources and abilities to solve problems

Able to build and maintain positive relationships with management, peers, and subordinates

30% travel required

This position can be remotely based or office based. If Remote, regular visit to main site will be expected