Senior Director, Companion Diagnostics

What this role involves

The Senior Director, Companion Diagnostics oversees laboratory activities for companion diagnostics programs, ensuring regulatory compliance and scientific rigor. They lead assay development, validation, and team mentoring to support clinical and non-clinical studies for cell therapy clients.

Skills this posting asks for

• fda guidance
• iso 13485
• iso 15189
• clia
• clsi
• companion diagnostics
• cell therapy assays
• assay development
• regulatory compliance
• gxp
• design control
• client management
• team mentoring
• lab operations
• large molecule regulated bioanalysis
• assay validation
• quality assurance
• protocol development
• study compliance
• operational excellence
• kpi monitoring
• inventory management
• sop development
• cross-functional coordination

Requirements

• Level: director
• Remote policy: onsite

From the employer’s posting

Position Summary: The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx progr…