Senior Clinical Omics Director

3 weeks ago

Reston, Virginia, United States Connect Life Sciences Full time

We are seeking a highly skilled and experienced Senior Clinical Omics Director to lead our client's clinical genomics services. With a strong foundation in Next-Generation Sequencing (NGS) technologies, the ideal candidate will oversee the clinical service team, focusing on clinical testing and service delivery. This role ensures compliance with CLIA regulations, quality standards, and safety protocols while driving the development of new clinical offerings. As a technical and scientific leader, this individual will spearhead the expansion of service capabilities and act as a liaison between the laboratory and commercial teams.

Our client is a leading CLIA-certified laboratory specializing in high-complexity tests utilizing NGS. Their mission is to provide innovative genomic services, maintaining the highest standards of quality and regulatory compliance.

Key Responsibilities

Leadership and Management:

  • Oversee daily operations of the CLIA laboratory, ensuring compliance with CLIA and CAP guidelines.
  • Lead the development, validation, and implementation of new clinical assays, scaling operations as needed.
  • Drive strategies to improve laboratory efficiency and service quality.
  • Manage recruitment, training, and performance of laboratory staff.
  • Collaborate with research and commercial teams to align clinical operations with business objectives and client needs.

Clinical Testing and Quality Control:

  • Ensure timely and accurate execution of clinical testing projects.
  • Maintain and update quality control protocols, revising SOPs as necessary to align with regulatory and technological advancements.
  • Monitor laboratory performance metrics, such as turnaround times (TAT), accuracy, and customer satisfaction.

Financial and Operational Oversight:

  • Develop and manage the laboratory budget, ensuring cost-effective operations without compromising quality.
  • Identify and integrate new technologies to enhance testing capabilities and expand service offerings.

Collaboration and Communication:

  • Work closely with commercial teams to understand client requirements and deliver exceptional clinical services.
  • Represent the laboratory in client meetings and presentations, communicating service capabilities and project outcomes.
  • Foster a culture of collaboration and continuous improvement within the team.

Qualifications:

  • Ph.D. in Genetics, Molecular Biology, Biology, Bioinformatics, or related field.
  • Expertise in NGS technologies and a strong understanding of their clinical applications.
  • 5+ years of experience in an NGS-based molecular diagnostic clinical laboratory.
  • Proficiency in scientific writing and communication.
  • Strong interpersonal skills, with the ability to conduct scientific interviews and deliver training.
  • CLIA laboratory personnel qualification required.
  • MB(ASCP) certification (including MLT or CLS certification) or comparable qualifications preferred.
  • Experience as a Technical Supervisor in a CLIA laboratory preferred.

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