Executive Director of Companion Diagnostics / Site Head

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

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicab…