Executive Director of Companion Diagnostics/Site Head

Responsibilities

• Provide full operational oversight of laboratory functions in Frederick, MD, including Bioanalysis, Flow Cytometry, and Companion Diagnostics
• Establish and monitor KPIs such as quality, turnaround time, capacity, and budget adherence
• Lead, hire, coach, and develop high-performing laboratory and scientific teams
• Provide strategic and technical oversight for the development and validation of cell-based and non-cell-based assays
• Ensure compliance with FDA, IVDR, ISO 13485, ISO 15189, CLIA, CLSI, CAP, and GxP requirements
• Lead CDx programs from concept through development, validation, and commercialization
• Manage client relationships and serve as a senior scientific representative
• Support business development through proposal development and technical input

Requirements

• PhD in Immunology or a related scientific field
• 20 years of relevant experience, including 4 years in industry
• 12 years of experience as a functional manager
• Demonstrated leadership managing multi-functional laboratory teams
• Deep expertise in Companion Diagnostics within Cell and Gene Therapy
• Strong knowledge of FDA guidance and global regulatory frameworks
• Proven experience developing and validating assays for clinical studies
• Experience with regulatory audits and agency interactions
• Proficiency in Microsoft Office

Preferred Qualifications

• Experience within a CRO, biotechnology, or pharmaceutical organization
• Expertise in Ligand-binding assays (LBA)
• Expertise in Electrochemiluminescence (ECL)
• Expertise in Flow cytometry
• Expertise in Cell-based plate assays
• Expertise in Enzymatic activity assays

About the Company

Precision Medicine Group is a leader in advancing precision medicine through specialized laboratory services and scientific expertise.