Precision Medicine Group
Companion Diagnostics
ExecutiveDirectorofCompanionDiagnostics/SiteHead
Neural analysis suggests this role is
optimal for Director candidates.
“Executive Director of Companion Diagnostics / Site Head at Precision Medicine Group. Skills: Companion Diagnostics, Cell and Gene Therapy, Laboratory Operations Leadership, Assay Development and Validation, Regulatory Compliance. Overseeing laboratory operations across multiple functional areas. Leading CDx programs from early development through commercialization”
What You'll Achieve.
Ensure scientific excellence; Ensure operational efficiency; Ensure full regulatory compliance; Ensure scientific rigor, reproducibility, and alignment with industry best practices; Maintain audit readiness; Streamline deliverables and enhance operational efficiency
Industry & Context.
Troubleshoot complex scientific issues and guide teams toward effective solutions
What They're Looking For.
Must Have
D. in Immunology or a related scientific field, 20 years of relevant experience, at least 4 years in industry, 12 years as a functional manager, Demonstrated leadership experience managing multi-functional laboratory teams, Deep expertise in Companion Diagnostics, particularly within Cell and Gene Therapy, knowledge of FDA guidance and global regulatory frameworks (IVDR, ISO 13485/15189, CLIA, CLSI, CAP, GxP), Proven experience developing and validating assays to support clinical studies, Experience participating in regulatory audits and agency interactions, Excellent leadership, communication, and stakeholder management skills, Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Nice to Have
Experience within a CRO, biotechnology, or pharmaceutical organization, Expertise across multiple assay platforms, including: Ligand-binding assays (LBA), Electrochemiluminescence (ECL), Flow cytometry, Cell-based plate assays, Enzymatic activity assays
What You'll Do.
Overseeing laboratory operations across multiple functional areas
Leading CDx programs from early development through commercialization
Building scalable laboratory operations
Advancing assay development
Providing full operational oversight of all laboratory functions
Establishing and monitoring key performance indicators (KPIs)
Driving operational excellence
and developing high-performing teams
Providing strategic and technical oversight for development and validation of cell-based and non-cell-based assays
Serving as a subject matter expert in CDx assay development
Ensuring compliance with all applicable regulatory standards
Leading and supporting regulatory interactions
Reviewing and approving protocols
and technical documentation
Leading CDx programs from concept through development
and lifecycle management
Coordinating cross-functional activities
Serving as a senior scientific and operational representative to clients
Managing client relationships
Providing technical updates and strategic guidance
Representing the organization within the broader companion diagnostics and Cell & Gene Therapy community
Contributing to proposal development
and client presentations
Providing technical input into business development opportunities and strategic initiatives
How You'll Work.
Team & Collaboration
Partner with cross-functional teams including Facilities, Biorepository, Quality Assurance, Site Leadership, and Finance; Collaborate with Quality Assurance and Regulatory Affairs; Coordinate cross-functional activities; Provide technical updates and strategic guidance to internal and external stakeholders
Communication Scope
Excellent communication skills; Stakeholder management skills; Client engagement; Provide technical updates and strategic guidance to internal and external stakeholders
Process & Methodology
Program & Product Lifecycle Management, Adherence to design control principles
Full Job Description
Position Summary: The Executive Director, Companion Diagnostics (CDx) / Site Head is a senior leadership role responsible for overseeing laboratory operations across multiple functional areas in Frederick, Maryland, including Bioanalytical, Flow Cytometry, and Companion Diagnostics. This role leads CDx programs from early development through commercialization while ensuring scientific excellence, operational efficiency, and full regulatory compliance. The position requires deep expertise in companion diagnostics within the Cell and Gene Therapy space, including a strong working knowledge of FDA guidance and global regulatory frameworks. The Executive Director will play a critical role in building scalable laboratory operations, advancing assay development, and positioning the organization as a leader in CDx innovation. Essential functions of the job include but are not limited to: Site & Operational Leadership Provide full operational oversight of all laboratory functions in Frederick, MD, including Bioanalysis, Flow Cytometry, and Companion Diagnostics Establish and monitor key performance indicators (KPIs) such as quality, turnaround time, capacity, revenue delivery, and budget adherence Drive operational excellence through efficient resource allocation, capacity planning, and process optimization Partner with cross-functional teams including Facilities, Biorepository, Quality Assurance, Site Leadership, and Finance Leadership & Talent Development Lead, hire, coach, and develop high-performing teams, including laboratory heads and scientific staff Foster a culture of accountability, collaboration, and continuous improvement Mentor scientists and technical staff to ensure high-quality, compliant data generation Scientific & Technical Leadership Provide strategic and technical oversight for development and validation of cell-based and non-cell-based assays Ensure scientific rigor, reproducibility, and alignment with industry best practices Serve as a subject matter
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