Senior Director, Companion Diagnostics — FDA‑Regulated CDx

Precision Medicine Group; 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

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in Frederick, MD, is seeking a Senior Director, Companion Diagnostics, to oversee laboratory activities supporting both commercial CDx analyses and development programs. The role requires deep FDA guidance knowledge, leading design, development and validation of cell therapy assays, and ensuring compliance with ISO 13485, CLIA, CLSI, and related standards.

The candidate will mentor staff, drive regulatory alignment with QA and Regulatory, and coordinate cross-functional

Qualifications

• PhD in Immunology or related field required.
• 18+ years relevant experience with leadership experience of 12+ years.
• Direct experience in companion diagnostics for Cell & Gene Therapy regulatory guidance and best practice.

Responsibilities

• Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
• Work with Lab Director to identify continuing education for laboratory personnel.
• Direct staff to ensure scientific standards and regulatory compliance across projects.
• Monitor KPIs and provide updates to senior leadership on quality, TAT, and volumes.

Skills

Leadership

Regulatory compliance

Project management

Communication

GLP/CLIA knowledge

Education

PhD in Immunology or related field

18+ years' relevant experience

12+ years' leadership experience

Tools

ELISA

MSD

Luminex

Quanterix

SPR technologies

Job description

Precision Medicine Group in Frederick, MD, is seeking a Senior Director, Companion Diagnostics, to oversee laboratory activities supporting both commercial CDx analyses and development programs. The role requires deep FDA guidance knowledge, leading design, development and validation of cell therapy assays, and ensuring compliance with ISO 13485, CLIA, CLSI, and related standards.

The candidate will mentor staff, drive regulatory alignment with QA and Regulatory, and coordinate cross-functional