Senior Director, Companion Diagnostics — Cell Therapy

Precision Medicine Group; Frederick (MD); On-site; USD 203,000 - 305,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance and disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Senior Director, Companion Diagnostics to lead onsite in Frederick, MD. You will oversee laboratory activities for CDx sample analysis, guide assay development and validation, and ensure compliance with FDA guidance and ISO/CLIA standards across cell-based and non-cell-based assays.

The role requires deep regulatory knowledge, mentoring staff, and coordinating with QA, Regulatory, and project managers to deliver timely client communications and regulatory

Qualifications

• PhD in Immunology or related field.
• 18+ years’ relevant experience.
• 12+ years' leadership experience.

Responsibilities

• Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
• Direct staff to ensure consistent scientific standards and regulatory expectations on all projects.
• Monitors and provides metrics, KPIs to senior leadership including quality metrics, TAT, assay failure rate, volumes and revenue.
• Monitors inventory and lab supplies; ensures staff perform inventory counts and update inventory software.
• Ensure lab is run efficiently, reviews processes, SOPs and implements improvements for operational excellence.
• Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team.
• Participate actively in the companion diagnostics community to stay updated on guidance.
• Participate in product development, commercialization and lifecycle management.
• Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements.
• Oversee execution of all work to ensure study compliance and budget adherence.
• Troubleshoot and resolve scientific issues within the team.
• Prepare/review/write protocols, reports, and SOPs.
• Collaborate with other technical teams for resource sharing and expertise.
• Maintain and support safe lab practices and environment.
• Carry out other duties/projects as assigned.

Skills

Leadership

Supervisory experience

Companion Diagnostics

Cell-based assays

Regulatory compliance

GxP/CLIA/CAP

Communication skills

ELISA/Luminex/SPR

Project management

Laboratory operations

Education

PhD in Immunology or related field

Tools

MS Word

Excel

PowerPoint

Job description

Precision Medicine Group is seeking a Senior Director, Companion Diagnostics to lead onsite in Frederick, MD. You will oversee laboratory activities for CDx sample analysis, guide assay development and validation, and ensure compliance with FDA guidance and ISO/CLIA standards across cell-based and non-cell-based assays.

The role requires deep regulatory knowledge, mentoring staff, and coordinating with QA, Regulatory, and project managers to deliver timely client communications and regulatory