Director, Clinical Development – Lead Medical Monitor

Responsibilities

• Support BeOne Clinical and Medical assets by successful execution of clinical development programs
• Jointly develop clinical program strategy and assure execution within expected scope, budget, and timelines
• Facilitate generation of, author, update, and review key documents
• Partner with clinical operations and other functional areas for successful implementation of clinical studies
• Provide scientific expertise for selection of investigators and vendors
• Train BeOne colleagues, CRO staff, and study site staff
• Provide scientific and medical support during clinical trials
• Review, query, and analyze clinical trial data
• Interpret and present clinical trial data
• Create and present clinical study or program‑related slide decks
• Build and maintain opinion leader/investigator networks

Requirements

• 5+ years of experience in biotech and/or pharmaceutical companies
• MD or foreign equivalent
• Previous participation in clinical development programs across all stages of clinical trials
• Clinical oncology experience preferred; exceptional experience in other therapeutic areas may be considered
• Expert understanding of global clinical study design and drug development process
• High level of communication (written and verbal) and interpersonal skills
• Knowledge of GCP and ICH Guidelines
• Flexibility to work with colleagues in a global setting
• Ability to engage in work‑related travel of approximately 25%
• Experience with development and support of related SOPs and policies
• Knowledge of industry‑standard Clinical Development IT solutions