Head of Scientific Laboratory Operations

Sonic Clinical Trials; Sydney; On-site; AUD 250,000 - 360,000; Full time

Job summary

Sonic Clinical Trials (SCT) is seeking an exceptional scientific leader to join our executive team as Head of Scientific Laboratory Operations. This global role ensures scientific integrity, quality, and operational performance of SCT's laboratory services across networks and partners.

Reporting to the CEO, you will lead pathology, molecular diagnostics, biomarker testing and biorepository operations, driving governance, standardisation, and high standards of data integrity for clients worldwide.

Qualifications

• PhD in Biomedical Science, Molecular Biology, or a closely related field.
• Minimum 15 years of experience in regulated clinical or laboratory environments.
• Proven leadership of multidisciplinary laboratory teams within complex organisations.
• Deep technical expertise across pathology, molecular diagnostics, biomarker testing and regulated lab operations.
• Strong governance, quality improvement initiatives and risk management programs.

Responsibilities

• Provide strategic leadership for all laboratory operations, including central and referral networks.
• Establish and maintain governance frameworks across global laboratory operations.
• Lead investigations into significant laboratory quality events and technical deviations.
• Oversee assay validation, verification, and implementation across disciplines.
• Drive harmonisation of scientific practices and standardised methodologies across regions.
• Partner with regional leaders to implement training programs and metrics.
• Ensure compliance with regulatory standards (NATA, CAP, CLIA, ISO).

Skills

Leadership

Regulatory compliance

Data integrity

Quality systems

Stakeholder engagement

Education

PhD in Biomedical Science

Job description

Sonic Clinical Trials (SCT) is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology and medical device clinical trials worldwide. As a wholly owned subsidiary of Sonic Healthcare, one of the world's largest specialist medical diagnostics organisations, SCT delivers scientifically rigorous laboratory solutions that support clinical research programs across all phases of development.

We are seeking an exceptional scientific leader to join our executive team as Head of Scientific Laboratory Operations.

This is a critical global leadership position responsible for ensuring the scientific integrity, technical excellence, quality, compliance and operational performance of all laboratory services delivered across SCT's internal laboratory network and external referral laboratory partners.

Reporting directly to the CEO, the successful candidate will serve as SCT's most senior laboratory scientific authority, providing strategic leadership across pathology, molecular diagnostics, biomarker testing, biorepository services and clinical trial laboratory operations. The role will be instrumental in strengthening scientific governance, advancing laboratory capability, driving global standardisation, and ensuring the highest standards of quality and reliability in all laboratory data generated on behalf of our clients.

This is a unique opportunity to shape the future of a growing global central laboratory business and drive scientific excellence across the US, Europe and Asia-Pacific regions.

The Opportunity

Scientific Leadership & Governance

• Serve as SCT's senior scientific leader responsible for laboratory science, assay performance, data integrity and technical excellence across all testing services.
• Establish and maintain a robust scientific governance framework across SCT's global laboratory operations.
• Lead scientific review and investigation of significant laboratory quality events, technical deviations, discordant results and emerging scientific risks.
• Ensure the scientific validity, accuracy and reliability of laboratory data reported to clients, sponsors and regulatory authorities.
• Provide expert scientific guidance to executive leadership, laboratory teams and clients on complex technical matters.
• Chair or lead scientific governance, technical review and laboratory standards committees as required.

Strategic Leadership & Laboratory Operations

• Provide strategic direction and oversight for all central laboratory functions, including pathology, histology, cytology, molecular diagnostics, biomarker testing and biorepository services.
• Develop and execute scientific and operational strategies that align with SCT's global growth objectives.
• Drive a culture of scientific excellence, quality, accountability and continuous improvement.
• Establish key scientific and operational performance metrics to monitor laboratory performance and service quality.
• Support the evaluation and implementation of emerging technologies, automation and innovative laboratory solutions.

Global Harmonisation

• Lead the harmonisation of scientific practices, quality systems, operational processes and laboratory standards across SCT's global network.
• Partner with regional laboratory leaders to implement standardised methodologies, procedures, training programs and performance metrics.
• Ensure consistency of scientific practices and laboratory service delivery across the US, Europe and Asia-Pacific regions.
• Promote knowledge sharing and scientific collaboration across geographically distributed teams.

Technical Excellence & Assay Oversight

• Oversee assay validation, verification and implementation activities across all laboratory disciplines.
• Provide leadership in evaluating new methodologies, instrumentation and technologies.
• Lead root cause investigations relating to assay performance, analytical variability and laboratory quality concerns.
• Ensure laboratory testing programs remain scientifically robust, fit-for-purpose and aligned with client and regulatory requirements.
• Drive continuous improvement in technical capabilities and laboratory performance.

Referral Laboratory Oversight

• Provide scientific oversight of SCT's global referral laboratory network.
• Support technical evaluation, qualification and ongoing performance monitoring of external laboratory partners.
• Ensure referral laboratories meet SCT's scientific, quality and regulatory expectations.
• Conduct scientific risk assessments and support technical audits of external providers.
• Establish governance processes to maintain high standards of quality and consistency across outsourced testing services.

Pre-Analytical & Biorepository Services

• Provide strategic leadership and oversight of SCT's global pre-analytical and biorepository operations.
• Lead the development, production and global distribution of clinical trial collection kits, ensuring accuracy, quality, scalability and study-specific compliance.
• Oversee all pre-analytical laboratory processes, including specimen receipt, accessioning, processing, tracking, reconciliation and chain of custody management.
• Ensure best practice standards for sample handling, storage, transportation, preservation and long-term biorepository management.
• Drive harmonisation of pre-analytical workflows and biorepository practices across all global laboratory locations.
• Ensure robust inventory management, sample traceability and data integration across laboratory and study systems.
• Maintain compliance with all applicable biobanking, regulatory, ethical and client-specific requirements relating to specimen management.

Quality, Compliance & Accreditation

• Champion a quality-first culture across all laboratory operations.
• Ensure laboratories operate within robust GxP-compliant quality systems.
• Partner closely with Quality Assurance and Regulatory teams to maintain inspection and audit readiness.
• Support accreditation activities and ensure compliance with applicable standards including CLIA, CAP, ISO 15189, GCLP, NATA and other relevant requirements.
• Act as an executive sponsor for laboratory quality, scientific excellence and data integrity initiatives.
• Build, mentor and develop high-performing scientific and operational teams.
• Foster a culture of accountability, collaboration, learning and professional growth.
• Support succession planning and capability development across the global laboratory organisation.
• Promote high standards of scientific competence, critical thinking and technical expertise throughout the business.

About You

Essential Qualifications & Experience

• PhD in Biomedical Science, Laboratory Medicine, Molecular Biology, Clinical Pathology, Translational Medicine or a closely related scientific discipline.
• Minimum 15 years' experience within regulated clinical, diagnostic, central laboratory, biotechnology, pharmaceutical or life sciences environments.
• Extensive leadership experience overseeing multidisciplinary scientific and laboratory teams within complex organisations.
• Deep technical expertise across pathology, molecular diagnostics, biomarker testing and regulated laboratory operations.
• Demonstrated experience leading scientific governance, quality improvement initiatives and technical risk management programs.
• Proven ability to investigate and resolve complex scientific and laboratory quality issues.
• Strong understanding of assay validation, method verification, laboratory quality systems and scientific data integrity.
• Thorough knowledge of global laboratory accreditation and regulatory frameworks including NATA, CAP, CLIA, GCLP and ISO standards.
• Exceptional leadership, communication and stakeholder engagement skills.

Highly Desirable

• Experience within a global central laboratory, CRO, pharmaceutical or biotechnology organisation.
• Experience managing both internal laboratory operations and external referral laboratory networks.
• Previous responsibility for accredited laboratory environments and regulatory inspections.
• Recognised expertise within laboratory science, clinical research or diagnostic services.
• Track record of driving laboratory transformation, harmonisation and scientific excellence programs across multiple regions.

Why Join SCT?

At SCT, you will have the opportunity to shape the scientific direction of a growing global clinical trials laboratory business and work alongside some of the most experienced professionals in laboratory medicine, clinical research and diagnostics.

This role offers the opportunity to lead meaningful change, strengthen laboratory excellence, and contribute directly to the integrity and success of clinical trials conducted around the world.

Background checks, including a Nationally Coordinated Criminal History Check, will be required prior to commencement. Please no agency applications and only those with appropriate working rights should apply.