Laboratory Director, Molecular Diagnostics – Research Triangle, NC

Role Overview for Laboratory Director, Molecular Diagnostics – Research Triangle, NC

JRG Partners is proud to represent a premier, rapidly growing biotechnology organization at the forefront of molecular diagnostics. We are seeking an exceptional and visionary Laboratory Director to join their team in the heart of the vibrant Research Triangle Park (RTP) in North Carolina. This is a pivotal leadership role responsible for the overall scientific, technical, and operational direction of a state-of-the-art, high-complexity clinical laboratory. The successful candidate will be the driving force behind the laboratory’s commitment to quality, accuracy, and regulatory compliance, ensuring that every test result meets the highest standards of excellence. As the Laboratory Director, you will not only oversee day-to-day operations but also play a crucial role in the strategic growth and innovation of the company’s diagnostic portfolio. You will lead a dedicated team of scientists and technicians, fostering a culture of collaboration, continuous improvement, and scientific curiosity. This position offers a unique opportunity to make a profound impact on patient care by ensuring the delivery of reliable and cutting-edge diagnostic services, while working within one of the world’s most dynamic hubs for life sciences research and development. If you are a strategic leader with deep expertise in molecular diagnostics and a passion for advancing healthcare, we invite you to apply for this career-defining role.

Key Responsibilities of Laboratory Director, Molecular Diagnostics – Research Triangle, NC

The Laboratory Director will have comprehensive oversight of all laboratory functions. Responsibilities are broad and require a blend of scientific expertise, regulatory knowledge, and strong leadership skills. Key duties include:

Strategic Leadership and Personnel Management

Provide overall leadership, vision, and direction to the entire laboratory team. This includes recruiting, hiring, training, mentoring, and conducting performance evaluations for all laboratory personnel, from senior scientists to technicians. You will be responsible for structuring the team for optimal efficiency, fostering a positive and collaborative work environment, and promoting professional development to ensure the team remains at the cutting edge of the field.

Regulatory and Quality Assurance Oversight

Serve as the designated CLIA Laboratory Director, holding ultimate responsibility for the laboratory’s compliance with all applicable regulations. Ensure the facility consistently meets and exceeds standards set by CLIA, CAP, state, and other federal regulatory bodies. You will personally lead all regulatory inspections, oversee the development and maintenance of the Quality Management System (QMS), manage proficiency testing programs, and ensure all quality control and assurance protocols are rigorously followed and documented.

Scientific and Technical Direction

Act as the final authority on all technical and scientific matters within the laboratory. Provide expert oversight for the entire testing lifecycle, from pre-analytical sample processing to post-analytical result interpretation and reporting. This includes providing guidance on complex molecular diagnostic techniques such as Next-Generation Sequencing (NGS), qPCR, digital PCR, and other advanced genomic assays. You will lead troubleshooting efforts for complex technical issues and ensure the scientific integrity of all laboratory data.

Assay Development and Validation

Lead the scientific and technical teams in the evaluation, validation, and implementation of new diagnostic assays and laboratory technologies. You will collaborate closely with the Research and Development (R&D) department to successfully transfer novel assays from a research environment into a robust, validated clinical workflow. This involves designing validation studies, authoring comprehensive validation reports, and developing standard operating procedures (SOPs).

Operational and Financial Management

Manage the laboratory’s operational budget, including forecasting, resource allocation, and cost control. You will be responsible for identifying opportunities for process improvements to enhance efficiency, reduce turnaround times, and manage costs effectively. This also includes overseeing capital equipment acquisition, laboratory information management systems (LIMS), and supply chain management to ensure uninterrupted operations.

Cross-Functional Collaboration

Serve as a key member of the company’s leadership team, working collaboratively with other departments including R&D, Bioinformatics, Clinical Affairs, Business Development, and Commercial teams. You will provide essential scientific and clinical input to support strategic initiatives, product development, and commercialization efforts. You will also represent the laboratory to external stakeholders, including clinicians, pharmaceutical partners, and academic collaborators.

Requirements for the Laboratory Director, Molecular Diagnostics – Research Triangle, NC

Candidates must possess a strong background in science and leadership, with a proven track record in a clinical diagnostic setting. The ideal candidate will meet the following qualifications:

Education

An M.D. or Ph.D. in a relevant scientific discipline such as Molecular Biology, Genetics, Genomics, Biochemistry, or a related field is required.

Certification and Licensure

Must hold current board certification from the American Board of Medical Genetics and Genomics (ABMGG), the American Board of Bioanalysis (ABB), or an equivalent and recognized certifying board. The candidate must meet all personnel qualifications to serve as a Laboratory Director for a high-complexity laboratory under federal CLIA regulations.

Experience

A minimum of 7 years of post-doctoral experience within a high-complexity clinical molecular diagnostics laboratory is required. This must include at least 4 years of progressive leadership experience in a CLIA/CAP-accredited environment (e.g., Assistant Director, Associate Director, or Director).

Technical Expertise

Demonstrated, in-depth, hands-on experience with a broad range of molecular diagnostic platforms and methodologies is essential. Extensive experience with Next-Generation Sequencing (NGS) workflows, from library preparation to data analysis, is strongly preferred. Proficiency with qPCR, RT-PCR, digital PCR, and other nucleic acid technologies is also required.

Regulatory Knowledge

A comprehensive understanding of all applicable clinical laboratory regulations, including CLIA, CAP, and state-specific requirements (as applicable). Proven, direct experience successfully leading regulatory audits and inspections is mandatory.

Leadership Skills

Exceptional leadership and management skills with a demonstrated ability to build, mentor, and motivate high-performing scientific teams. Must possess excellent interpersonal, verbal, and written communication skills, with the ability to convey complex scientific concepts to diverse audiences.

Analytical Abilities

Strong analytical, problem-solving, and critical thinking skills are essential. The candidate must be meticulous, detail-oriented, and capable of making sound decisions under pressure.

Benefits & Perks Offered

Our client is committed to attracting and retaining top talent by offering a comprehensive and competitive benefits package, including:

Highly competitive base salary and significant performance-based annual bonus potential.

Comprehensive benefits package, including premium medical, dental, and vision insurance for employees and their dependents.

A robust 401(k) retirement savings plan with a generous company match.

Generous Paid Time Off (PTO) policy, including vacation, sick leave, and paid company holidays.

Substantial opportunities for professional growth and development, including support for attending scientific conferences and continuing education.

Relocation assistance may be available for highly qualified candidates.

An opportunity to work in a collaborative, innovative, and mission-driven culture dedicated to improving patient outcomes.

A prime location in Research Triangle Park, NC, a world-renowned center for technology and life sciences with a high quality of life.

How to Apply

If you are a visionary leader in molecular diagnostics ready to take on a new challenge and make a significant impact, we encourage you to apply for this outstanding opportunity. JRG Partners is the exclusive recruitment partner for this search. To be considered, please submit your curriculum vitae (CV) and a detailed cover letter that highlights your qualifications, leadership philosophy, and experience relevant to this role. We look forward to reviewing your application. For more information or to discover other career-defining roles, please visit our Molecular Technologist Recruiters Practice Area page .