Executive Director of Companion Diagnostics / Site Head

Precision for Medicine•Frederick, MD

8d•Onsite

About The Position

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.

Requirements

Ph.D. 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)

Nice To Haves

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

Responsibilities

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