Head of Laboratory

London
16 hours ago
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Head of Regulated Core Labs - permanent, full-time

Location: London

Hours: 40 hours per week

Role overview

This position leads a regulated Core Lab services programme, delivering high-quality biomarker testing for clinical trials. You will oversee assay validation (including mass spectrometry and additional platforms), ensure compliance with relevant clinical standards, and manage project delivery against sponsor timelines. The role combines scientific leadership, operational oversight, client engagement, and people development in a regulated laboratory environment.

Key responsibilities

  • Lead the regulated Core Lab services programme and drive delivery across clinical biomarker projects.

  • Validate mass spectrometry assays to appropriate clinical standards (e.g., ISO 15189, CLIA, GCLP).

  • Evaluate and validate additional assay platforms (e.g., NuLISA).

  • Design and execute complex experiments; analyse, interpret, and report data with limited supervision.

  • Assess feasibility and viability of new assays and methodologies.

  • Manage day-to-day operations for biomarker studies in clinical trials, ensuring delivery within scope and sponsor timelines.

  • Prepare, maintain, and file essential trial and project documentation (e.g., protocols, data transmittal forms) in line with quality requirements.

  • Own key project processes and documentation (e.g., project management, communication, escalation, risk plans) and maintain records within relevant CTMS.

  • Produce metrics and reporting for clients and senior stakeholders.

  • Support pre-sales activity by contributing to methodologies, procedures, and pipelines.

  • Create and contribute to SOPs for both the overall service and individual studies.

  • Engage directly with customers and external study teams, including attending progress meetings as required..

  • Train and supervise junior staff.

  • Travel (domestic and international) may be required.

  • Undertake additional duties aligned to the role, as requested by the line manager.

    Skills and experience

  • Degree in biochemistry or a closely related biomedical discipline (essential).

  • 5+ years’ hands-on experience operating mass spectrometry equipment and developing methods (essential).

  • Proven experience in mass spectrometry data analysis and assay development (essential).

  • Experience handling human samples in a research or clinical lab setting (essential).

  • Experience delivering mass spectrometry biomarker projects and/or supporting clinical trials in a regulated environment (desirable).

  • Quality/compliance experience within clinical trials settings and/or clinical mass spectrometry (desirable).

  • Strong written and spoken English (essential).

  • Ability to analyse, interpret, and write up data clearly (essential).

  • Confident communicator with strong interpersonal skills (essential).

  • Strong IT skills (Word, Excel, Access, PowerPoint) (essential).

  • Ability to troubleshoot equipment issues and maintain accurate records (essential).

    Personal attributes

  • Commitment to translational research, with sound judgement on when to seek support (essential).

  • Willingness to learn and adapt to new techniques (essential).

  • Collaborative team player who can also work independently and effectively (essential)

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