Global Clinical Affairs Director — Studies & Operations

bdx

Milpitas (CA)

On-site

USD 184,000 - 294,000

Full time

9 days ago

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Job summary

BD recognizes the strategic value of clinical evidence and seeks an Associate Director, Clinical Affairs to lead global operations for Waters Biosciences. The role oversees clinical studies, collaborates with Regulatory, R&D, and Quality, and drives performance metrics.

A strong background in IVD/ genomics and leadership is essential to advance regulatory objectives and evidence generation. Top candidates will mentor a global team and work across divisions to optimize execution, budgets, and CRO

Qualifications

Bachelor's degree in life sciences or related field is required.
Minimum 10 years in clinical research, operations, or affairs with global scope.
Experience with IVD, molecular diagnostics, genomics or proteomics is highly desirable.

Responsibilities

Lead global clinical studies from start-up to closeout with timelines and budgets.
Provide oversight of study management, monitoring, enrollment, and site management.
Manage CROs, labs, investigators and external vendors for quality and timeliness.
Develop dashboards and KPIs to track progress, risk, and performance.
Mentor and develop a global Clinical Project Manager team and CRAs/Monitors.