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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 expert in CDx assay development, including bioanalytical and flow cytometry platforms
• Troubleshoot complex scientific issues and guide teams toward effective solutions

Regulatory & Quality Compliance

• Ensure compliance with all applicable regulatory standards, including FDA, IVDR, ISO 13485, ISO 15189, CLIA, CLSI, CAP, and GxP requirements
• Lead and support regulatory interactions, including FDA meetings and audits
• Review and approve protocols, validation reports, and technical documentation
• Partner closely with Quality Assurance and Regulatory Affairs to maintain audit readiness

Program & Product Lifecycle Management

• Lead CDx programs from concept through development, validation, commercialization, and lifecycle management
• Ensure adherence to design control principles and regulatory expectations throughout the product lifecycle
• Coordinate cross-functional activities to streamline deliverables and enhance operational efficiency

Client & External Engagement

• Serve as a senior scientific and operational representative to clients
• Manage client relationships, expectations, and escalations
• Provide technical updates and strategic guidance to internal and external stakeholders
• Represent the organization within the broader companion diagnostics and Cell & Gene Therapy community

Business Development Support

• Contribute to proposal development, grant applications, and client presentations
• Provide technical input into business development opportunities and strategic initiatives

Qualifications:

Minimum Required:

• PhD in Immunology or a related scientific field
• 20 years of relevant experience, including at least 4 years in industry and including 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
• Strong 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)

Preferred:

• 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