Senior Director, Companion Diagnostics: Regulatory Lead

Precision Medicine Group, LLC.; Frederick (MD); On-site; USD 203,200 - 304,800; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group, LLC. is seeking a Senior Director, Companion Diagnostics to oversee lab activities in Frederick, MD.

The role focuses on cell therapy assay design, development and validation to support both commercial CDx and developmental programs, with strong emphasis on FDA guidance, ISO 13485, and CLSI/CAP/CLIA compliance. The ideal candidate will mentor staff, manage cross-functional projects, and collaborate with QA/Regulatory to ensure delivery and client satisfaction.

Qualifications

• PhD in Immunology or related field required.
• Deep regulatory knowledge for companion diagnostics and cell therapy.
• Experience with GLP, GCP or GCLP standards and ISO 13485.
• Direct experience with cell-based assays used for regulated studies.

Responsibilities

• Lead and mentor companion diagnostic teams to ensure high quality, compliant data.
• Collaborate with QA and Regulatory to ensure compliance and timely client communication.
• Review development and validation protocols and reports to meet CAP/CLIA/CLSI requirements.
• Oversee lab operations and budget, drive process improvements and efficiency.

Skills

PhD in Immunology

Leadership

Supervisory experience

Companion Diagnostics

Cell-based assays

Regulatory knowledge

GLP/GCP/GCLP

CAP/CLIA/CLSI ISO13485

Microsoft Office

English communication

Education

PhD in Immunology or related field

Job description

Precision Medicine Group, LLC. is seeking a Senior Director, Companion Diagnostics to oversee lab activities in Frederick, MD.

The role focuses on cell therapy assay design, development and validation to support both commercial CDx and developmental programs, with strong emphasis on FDA guidance, ISO 13485, and CLSI/CAP/CLIA compliance. The ideal candidate will mentor staff, manage cross-functional projects, and collaborate with QA/Regulatory to ensure delivery and client satisfaction.