Clinical Program Director leading global clinical development programs in the biopharmaceutical sector. Ensuring excellence in stakeholder management and clinical operations oversight across various therapeutic areas.
Responsibilities
Holds full accountability for global clinical development programs
Drives excellence in external stakeholder management
Manages relationships with service providers
Oversees clinical operations strategy and compliance
Requirements
10+ years of Clinical Operations experience in Pharma, Biotech or CRO organization
Experience in managing pivotal filing studies and global submissions
Knowledge of the drug development process
Experience in preparation and review of clinical study documents
Thorough knowledge of FDA and EMA regulations and GCP guidelines
Strong organizational and management skills
Proficient in risk management and budgeting for clinical studies
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