Associate Director, Global Clinical Affairs

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

Job summary

Waters Biosciences seeks an Associate Director of Clinical Affairs to lead global clinical operations, shaping study execution and evidence generation. You will manage a small, global team, collaborate across Medical Affairs, Regulatory, R&D, and Quality, and ensure timely delivery within budgets and high quality standards.

Ideal candidates will have 10+ years in clinical research/operations with leadership and deep regulatory knowledge, particularly in IVD, genomics, and proteomics contexts,

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years in clinical research, clinical operations, or clinical affairs with leadership responsibilities.
• Proven track record delivering global or multi-center studies through teams, CROs, and cross-functional partners.
• Experience managing Clinical Project Managers and Clinical Research Associates/Monitors.
• Experience generating medical evidence for regulatory, post‑market, and reimbursement objectives.
• Strong FDA/ICH-GCP/ISO 14155 knowledge and global clinical regulations.
• Ability to review data and make informed decisions in diagnostic contexts.
• Experience overseeing CROs, sites, labs, and external vendors for studies.

Responsibilities

• Lead planning, execution, monitoring, and closeout of global clinical studies.
• Provide strategy for study management, monitoring, enrollment, site management, and risk mitigation.
• Contribute to study design, feasibility, enrollment strategies, and execution plans.
• Direct and manage CROs, sites, investigators, and labs for quality and timing.
• Oversee study budgets, contracts, and resource allocation across programs.
• Develop dashboards and KPIs to track progress and risks.
• Mentor a global team of Clinical Project Managers and CRAs/Monitors.
• Collaborate with Medical Affairs, Regulatory, R&D, and Quality on evidence plans.
• Support regulatory submissions and scientific communications with operational input.
• Drive continuous improvement including AI-enabled solutions for efficiency.

Skills

Leadership

Clinical operations

Budget management

Vendor management

Regulatory knowledge

Communication

Strategic thinking

Team development

Education

Bachelor's degree in life sciences

Tools

SOPs

GxP

Job description

Waters Biosciences seeks an Associate Director of Clinical Affairs to lead global clinical operations, shaping study execution and evidence generation. You will manage a small, global team, collaborate across Medical Affairs, Regulatory, R&D, and Quality, and ensure timely delivery within budgets and high quality standards.

Ideal candidates will have 10+ years in clinical research/operations with leadership and deep regulatory knowledge, particularly in IVD, genomics, and proteomics contexts,