Job Application for Executive Director of Companion Diagnostics / Site Head at Precision Medicine Group

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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:

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)

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 applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$227,600 - $341,400 USD

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Executive Director of Companion Diagnostics / Site Head

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