Global Director, Clinical Affairs & Evidence Generation

Becton, Dickinson and Company (BD); Milpitas (CA); On-site; USD 184,000 - 294,000; Full time

Job summary

Waters Corporation, within its Biosciences business, seeks an Associate Director of Clinical Affairs to lead global clinical studies, ensuring regulatory alignment and evidence generation across products. You will manage a small global team, collaborate with Medical Affairs, Regulatory, and R&D, and drive continuous improvement in clinical operations.

Role emphasizes leadership, strategic oversight, and partnering with external CROs and sites to deliver high-quality clinical data and

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years of clinical research, clinical operations, or clinical affairs experience with responsibility for clinical study execution.
• Experience delivering global or multi-center clinical studies through Clinical Project Managers and CROs.
• Strong working knowledge of FDA regulations, ICH-GCP, ISO 14155, and global clinical research regulations.
• Experience supporting global medical evidence-generation programs including regulatory and reimbursement objectives.
• Experience managing study budgets, vendor engagements, and portfolio-level metrics.
• Led teams or mentored Clinical Project Managers/CRAs with a collaborative approach.
• Experience with IVD, molecular diagnostics, genomics, or proteomics contexts.

Responsibilities

• Plan, execute, monitor, and close global clinical studies, ensuring delivery against timelines, budgets, and quality standards.
• Provide strategic oversight for study management, enrollment, site management, and risk mitigation.
• Collaborate with Medical Affairs, Regulatory, R&D, Quality, Data Management, and other stakeholders.
• Develop dashboards and KPIs to monitor progress and performance.
• Mentor and develop a global team of Clinical Project Managers and Clinical Research Associates/Monitors.
• Coordinate with CROs and external partners for study start-up, enrollment, monitoring, and closeout.
• Support development of clinical study reports, regulatory submissions, and scientific communications.

Skills

Project management

Leadership

Regulatory knowledge

Clinical operations

Vendor management

Communication skills

Strategic planning

Education

Bachelor's degree in life sciences

Job description

Waters Corporation, within its Biosciences business, seeks an Associate Director of Clinical Affairs to lead global clinical studies, ensuring regulatory alignment and evidence generation across products. You will manage a small global team, collaborate with Medical Affairs, Regulatory, and R&D, and drive continuous improvement in clinical operations.

Role emphasizes leadership, strategic oversight, and partnering with external CROs and sites to deliver high-quality clinical data and