Pathology Director
Introduction to role
Accountabilities
- Medical and Technical Oversight: Provide pathology oversight of assay performance, result review and reporting practices in an accredited environment supporting clinical and biomarker development.
- CAP/CLIA and GxP Compliance: Act in a role aligned to CAP/CLIA expectations; ensure testing and reporting practices meet regulatory and professional standards, including ISO 15189, GCP, IVDR and HTA requirements.
- Result Authorisation and Interpretation: Review, interpret and approve laboratory results and reports, ensuring outputs are scientifically valid, clinically appropriate and compliant with defined quality requirements; contribute to clinical and scientific interpretation of pathology and biomarker data.
- Method Evaluation and Approval: As technical lead, evaluate and approve novel test methods; ensure fitness for purpose and appropriate validation or verification before clinical use.
- Operational Partnership: Work closely with the Laboratory Director, QA/QC and operational leadership to evolve methods, procedures, instrumentation, staffing models and workflow design.
- Strategy and Companion Diagnostics: Provide scientific and medical input into assay and biomarker strategy, including companion diagnostic development and clinical implementation planning; align with broader clinical development objectives.
- Innovation and Digital Pathology: Drive continuous improvement and the introduction of emerging technologies, including digital pathology, image analysis and data-enabled diagnostic workflows.
- Clinical Trial Support: Provide medical and technical oversight for prospective patient testing in clinical studies, ensuring protocol-aligned reporting, documentation and quality standards.
- External Engagement and Governance: Represent the laboratory in governance forums; contribute to external regulatory interactions; lead capability-building in diagnostic pathology and companion diagnostics across matrix teams.
Essential Skills/Experience
- Medical degree recognised by the General Medical Council (GMC). - Current Licence to Practice in the United Kingdom.
- Significant experience practising at consultant pathologist level, or equivalent senior medical pathology role, within a diagnostic or regulated laboratory environment.
- Experience providing medical and technical oversight for testing within an accredited or regulated laboratory environment.
- Strong working knowledge of CAP/CLIA, ISO 15189, GCP, IVDR, HTA and applicable standards governing laboratory quality systems, patient testing, and report issuance.
- Experience reviewing, authorising, or providing medical oversight of laboratory reports, ensuring outputs are scientifically valid, medically appropriate, and compliant with regulatory and quality requirements.
- Ability to provide clear clinical and scientific interpretation of pathology and biomarker data, integrating findings with other data streams where relevant.
- Strong leadership, communication, and stakeholder management skills, with the ability to work effectively across matrix teams and provide oversight to multidisciplinary laboratory activities.
Desirable Skills/Experience
- GMC Specialist Registration in an appropriate pathology specialty.
- FRCPath in Histopathology or another relevant pathology discipline, or equivalent specialist qualification.
- PhD, MD(Res), or equivalent higher research qualification in pathology, oncology, translational medicine, biomarker science, or a related discipline.
- Experience in companion diagnostic and predictive biomarker development within pharmaceutical, biotechnology, or accredited diagnostic laboratory settings, working in line with ISO 13485 and ISO 14971.
- Experience serving in a role aligned to CAP Technical Supervisor, General Supervisor, or Laboratory Director responsibilities for high-complexity testing.
- Familiarity with digital pathology, image analysis, and computational pathology approaches in a regulated environment.
- Experience with diagnostic methods, such as PCR, NGS, spatial omics, proteomics, mass spectrometry and other platforms relevant to precision medicine.
- Experience leading or supporting clinical trial assay governance, including oversight of testing strategies, report processes, and protocol-aligned patient testing.
- Experience overseeing or contributing to prospective patient testing in support of clinical trials, including understanding of protocol-driven testing, result reporting, and documentation requirements.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca
Date Posted
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