Director, Precision Medicine Labs & Operations

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

Benefits offered by this job

Health insurance

Retirement plan

Life insurance

Disability insurance

Parental leave

Paid time off

Discretionary annual bonus

Job summary

Precision Medicine Group in Frederick, MD is seeking an Executive Director / Site Head of Precision for Medicine to oversee laboratory operations across Bioanalysis, Flow Cytometry, and CDx. The role drives regulatory compliance and scientific excellence while ensuring operational performance in a fast-paced environment.

Ideal candidates will possess deep knowledge of FDA guidance, ISO 13485/15189 design controls, and CLIA/CLS I validation, with hands-on leadership to mentor lab heads and

Qualifications

• PhD in Immunology or related field.
• 20+ years of relevant experience.
• 15+ years of leadership experience.
• Direct working experience and knowledge in cell-based assays / bioanalysis for supporting clinical studies.
• Solid understanding of GLP, GCP or GCLP standards.
• Working knowledge of CAP/CLIA, CLSI and ISO 13485.
• Experience hosting/regulatory audits.
• Excellent communication, interpersonal, organizational and multitasking skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Oversee operational aspects for all laboratories in Frederick MD including Bioanalysis, Flow Cytometry and CDx.
• Mentor and lead laboratory heads in Bioanalytical, Flow and CDx.
• Collaborate with Facilities, Biorepository, Quality Assurance, Finance, and global site heads.

Skills

Leadership experience

Regulatory knowledge

Communication skills

Project management

Education

PhD in Immunology or related field

Tools

Microsoft Office

Job description

Precision Medicine Group in Frederick, MD is seeking an Executive Director / Site Head of Precision for Medicine to oversee laboratory operations across Bioanalysis, Flow Cytometry, and CDx. The role drives regulatory compliance and scientific excellence while ensuring operational performance in a fast-paced environment.

Ideal candidates will possess deep knowledge of FDA guidance, ISO 13485/15189 design controls, and CLIA/CLS I validation, with hands-on leadership to mentor lab heads and