Associate Director, Clinical Affairs
Becton Dickinson & Co
Waters seeks an Associate Director of Clinical Affairs to lead global clinical study operations for the Biosciences business. The role oversees clinical project execution, manages a team of clinical professionals, and ensures regulatory compliance and evidence generation for in vitro diagnostics and related technologies.
Responsibilities
- Plan, execute, monitor, and close global clinical studies ensuring timeline, budget, and quality delivery
- Provide strategic oversight of study management, enrollment, site management, and risk mitigation
- Manage study budgets, contracts, vendor engagements, and resource allocation
- Lead and mentor global team of Clinical Project Managers and Clinical Research Associates
- Partner with cross-functional teams on clinical research planning and regulatory support
Requirements
- Bachelor's degree in scientific discipline or related life sciences field
- Minimum 10 years clinical research, clinical operations, or clinical affairs experience
- Proven track record delivering global or multi-center clinical studies
- Experience managing Clinical Project Managers and Clinical Research Associates
- Strong knowledge of FDA regulations, ICH-GCP, ISO 14155, and clinical research regulations
- Experience with in vitro diagnostics, molecular diagnostics, genomics, or proteomics
- Demonstrated vendor management and CRO oversight capabilities
$183.8k - $294.1k
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