Associate Director, Clinical Affairs
Core
Leads global clinical affairs operations for Waters Biosciences, executing clinical studies to support product development, regulatory objectives, and evidence generation for in vitro diagnostics and life sciences tools.
Role type
Senior IC Associate Director, Clinical Affairs
Builds
Global clinical study execution and evidence generation for diagnostic and life science products
Domain
Life Sciences / In Vitro Diagnostics (IVD) / Molecular Diagnostics
Required skills
Global clinical study execution, CRO and vendor management, regulatory compliance (FDA/ICH-GCP), team leadership, budget and portfolio management, cross-functional collaboration, process improvement, scientific data evaluation
Preferred skills
Advanced degree (MS/PhD/MD), SOCRA or ACRP certification
Technologies
AI-enabled operational tools
Responsibilities
Plan and execute global clinical studies ensuring timeline and budget delivery; Provide strategic oversight for study management, monitoring, and risk mitigation; Direct and hold accountable external partners (CROs, sites, labs) for quality and compliance; Manage study budgets, contracts, and resource allocation; Lead and mentor a global team of Clinical Project Managers and CRAs; Partner with Medical, Regulatory, and R&D teams on evidence generation plans; Drive continuous improvement of clinical operations processes and systems.
Seniority
Senior, hands-on IC with leadership responsibilities
