Associate Director, Clinical Development

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Associate Director, Clinical Development for Solid Tumors will support BeOne Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners.

As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Essential Functions of the job:

Facilitate generation of, author, update, and/or review key documents, including, but not limited to:

• Protocol concepts, synopses, protocols, and amendments.
• Informed consent documents.
• Investigator Brochures.
• Clinical study reports.
• Abstracts, posters and manuscripts.
• Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports.
• Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
• Risks / benefits analysis for applicable documents.
• Clinical Development Plans.

Additional Responsibilities:

• Partner with clinical operations and other functional areas for the successful imple...

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