Pathology Director

AstraZeneca; Cambridge; Hybrid; GBP 180,000 - 240,000; Full time

Job summary

AstraZeneca in Cambridge, UK is seeking a Director of Pathology to lead medical oversight of diagnostic assays for early-phase trials. This hybrid role requires strategic input into companion diagnostics and biomarker development, with responsibility across CAP/CLIA compliance and digital pathology initiatives.

The candidate will oversee assay validation, ensure quality standards, and drive clinical impact through biomarker-informed patient selection and trial support.

Qualifications

• Medical degree recognised by the GMC; current Licence to Practice in the United Kingdom.
• Significant experience as a consultant pathologist or senior medical pathology role in a regulated lab.
• Experience providing medical/technical oversight for testing in accredited environments.
• Strong knowledge of CAP/CLIA, ISO 15189, GCP, IVDR, HTA and related standards.
• Ability to interpret pathology and biomarker data and integrate with other data streams.
• Proven leadership and stakeholder management across matrix teams.

Responsibilities

• Provide pathology oversight of assay performance, result review and reporting in an accredited lab setting.
• Ensure testing and reporting meet CAP/CLIA, ISO 15189, GxP standards and regulatory requirements.
• Review, interpret and approve laboratory results and reports with clinical relevance.
• Lead evaluation and approval of new test methods for clinical use.
• Collaborate with QA/QC and operations to evolve methods, workflows and staffing.
• Contribute to biomarker strategy and companion diagnostic development for trials.
• Drive innovation in digital pathology and data-enabled diagnostic workflows.
• Provide medical oversight for prospective patient testing in clinical studies.
• Represent the lab in governance forums and regulatory interactions.

Skills

Clinical leadership

Medical oversight

Regulatory compliance

Biomarker strategy

Digital pathology

Stakeholder management

Education

GMC Licence to Practice

Consultant pathologist

GMC Specialist Registration

FRCPath

PhD/MD or equivalent

Job description

Job Title: Director of Pathology

Location: Cambridge, UK

Hybrid working: Minimum 3 days per week in the office

Introduction to role:

Are you ready to bring decisive medical leadership in pathology to accelerate personalised diagnostics that guide clinical trials and patient care? This is a chance to shape how novel biomarkers become trusted tests that identify the right patients for the right therapies, faster.

You will join our internal accredited laboratory delivering in-house diagnostic testing for early-phase clinical studies and pioneering approaches in patient stratification. Your oversight will ensure assays are robust, validated and clinically meaningful, directly influencing how our medicines are developed and how patients are selected for studies. Working at the intersection of pathology, quality, and translational science, you will help advance companion and complementary diagnostics- including computational pathology and image analysis-across a biomarker-driven portfolio.

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,