Senior Director, Companion Diagnostics — Regulatory Expert

Precision for Medicine; Frederick (MD); On-site; USD 203,200 - 304,800; 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 in Frederick, MD seeks a Senior Director, Companion Diagnostics to lead laboratory activities for CDx sample analysis in development and commercial settings. The role requires deep FDA guidance knowledge to design robust assays that pass scrutiny and align with ISO 13485, 15189, CLIA and CLSI standards.

You will mentor staff, drive GxP compliance, and oversee QA/Regulatory collaboration while coordinating with project managers to ensure timely client communication and

Qualifications

• PhD in Immunology or related field. 18+ years relevant experience and 12+ years leadership preferred.
• Deep knowledge of FDA companion diagnostics guidance and design control requirements.
• Experience with CLIA, CLSI, ISO 13485, CAP/CLIA and regulatory audits.

Responsibilities

• Mentor and lead all companion diagnostic teams to ensure compliant data.
• Direct staff to maintain scientific standards and regulatory expectations.
• Monitor KPIs and provide senior leadership with quality and throughput metrics.
• Coordinate cross-functional activities and ensure timely client communication.
• Prepare protocols, reports, and SOPs; support regulatory audits.

Skills

Leadership

Regulatory knowledge

GxP knowledge

Mentorship

Regulatory audits

Cell-based assays

Non-cell assays

Communication

Education

PhD in Immunology or related field

Tools

Word

Excel

PowerPoint

Job description

Precision Medicine Group in Frederick, MD seeks a Senior Director, Companion Diagnostics to lead laboratory activities for CDx sample analysis in development and commercial settings. The role requires deep FDA guidance knowledge to design robust assays that pass scrutiny and align with ISO 13485, 15189, CLIA and CLSI standards.

You will mentor staff, drive GxP compliance, and oversee QA/Regulatory collaboration while coordinating with project managers to ensure timely client communication and