The Director, Clinical-Translational Science will provide scientific leadership across AdvanCell's biobanking and clinical translational research activities, supporting the delivery of translational research aligned with clinical development objectives.

The role will provide scientific oversight and technical support for sample processing, storage, data management and analysis, ensuring all activities are conducted to the appropriate quality, safety and regulatory standards. The role will lead and coordinate translational research initiatives using clinical samples and data to identify and develop novel biomarkers and research, working collaboratively with AdvanCell's cross-functional teams and external partners.

It will also support the development and expansion of in-house research capabilities, scientific interpretation and communication, and the translation of research findings into insights that inform clinical development and research decision-making.

Key Responsibilities and Duties Biobanking and Research Operations

• Provide oversight of patient-derived biological sample collection, processing, storage, and utilisation, ensuring processes are timely, accurate and appropriately documented.
• Manage, train and mentor biobank technical staff, fostering a high-performance culture and supporting ongoing professional development.
• Develop, optimise and maintain sample processing protocols and Standard Operating Procedures (SOPs) in collaboration with relevant cross-functional teams.
• Ensure sample processing activities are performed consistently, accurately and with full traceability.
• Oversee biobank data capture and integrity, including maintenance of relevant databases and records.
• Ensure biobank operations, infrastructure and resources are appropriately planned to support current and future clinical studies and pipeline expansion.

Note: Some samples require immediate processing upon receipt at TRI, which may occasionally require work outside standard hours.

Clinical Translational Research

• Design, lead and coordinate innovative translational research strategy and programs in collaboration with AdvanCell's clinical and cross-functional teams and external partners, focused on the discovery and development of novel biomarkers and other approaches to advance clinical research.
• Apply robust scientific and operational approaches to ensure translational research activities align with AdvanCell's clinical development and corporate reseach objectives.
• Identify, evaluate and establish in-house research capabilities where feasible, including Multiplex ELISA, immune cell phenotyping, cfDNA/cfRNA analysis, PBMC-based sequencing and proteomics workflows.
• Contribute to experimental design, bioinformatics analyses and biological interpretation of multi-omics and other translational datasets.
• Translate translational research findings into scientific insights that inform clinical development and research decision-making.
• Identify opportunities to expand research activities through external collaborations and funding opportunities.

Scientific Leadership and Collaboration

• Provide scientific leadership, mentorship and technical guidance to research staff and scientific collaborators.
• Contribute scientific expertise to cross-functional project discussions, supporting research planning, project progression and decision-making.
• Develop and maintain effective relationships with internal teams, external research partners and other relevant stakeholders.
• Prepare and communicate scientific data and project updates through internal presentations, reports, publications and presentations at national and international conferences.

Data, Systems and Quality Oversight

• Ensure the integrity, quality and traceability of biobanking and translational research data.
• Oversee data workflows and systems to support efficient analysis, appropriate data storage and regulatory compliance.
• Maintain robust documentation and data management practices across biobanking and translational research activities.
• Promote and uphold AdvanCell's Quality Management System (QMS) and ensure quality and compliance across research and laboratory operations.

Other Responsibilities Laboratory Operations and Infrastructure

• Ensure the biobank team and infrastructure are equipped to meet current and future strategic demands, including new clinical studies or pipeline expansion.
• Oversee the maintenance, calibration and operational readiness of laboratory equipment and infrastructure.
• Ensure appropriate escalation and coordination of equipment servicing and repairs to minimise disruption to critical workflows.
• Provide oversight of inventory management processes, ensuring continuity of supplies and efficient resource utilisation.

Continuous Improvement and Innovation

• Stay abreast of emerging technologies and methodologies in biobanking, biomarker research and translational science.
• Identify opportunities to improve research workflows, laboratory capabilities, data processes and scientific output.
• Evaluate and implement new technologies and methodologies where they provide value to AdvanCell's research and clinical development programs.

Compliance, Governance and Documentation

• Ensure all laboratory and research activities comply with applicable institutional, ethical, radiation safety, workplace health and safety, and regulatory requirements.
• Maintain audit-ready documentation and accurate records across relevant research and laboratory activities.
• Ensure appropriate adherence to approved protocols, SOPs and quality systems.
• Promote a culture of compliance, quality and continuous improvement across research activities.
• Undertake other duties and responsibilities as directed by relevant management.

Essential Skills, Qualifications, Industry and Educational Requirements

• PhD in cancer biology, immunology, or a related discipline, or an equivalent combination of relevant experience and training.
• Background in immunology and/or clinical biomarker research, ideally within oncology or a related field.
• Demonstrated wet-lab expertise in human biospecimen handling, including processing and analysis of blood and urine samples (e.g., circulating nucleic acid extraction, protein quantification, QC, ELISA, flow cytometry).
• Appropriate immunisation status commensurate with processing human biobanking samples.
• Demonstrated ability to design, lead, and deliver innovative clinical translational research projects and manage multidisciplinary teams.
• Proven experience in liquid biopsy biomarker development.
• Proven experience working effectively within multidisciplinary and cross-functional teams.
• Excellent communication and interpersonal skills, with the ability to engage effectively with internal teams, external partners, and stakeholders.
• Strong organisational, prioritisation, and problem-solving skills, with the ability to manage competing priorities and meet deadlines in a dynamic environment.
• High level of attention to detail, ensuring accuracy, reproducibility, and rigorous documentation of experimental work.
• Adaptability and willingness to learn and implement new technologies and methodologies in a rapidly evolving research environment.

AdvanCell seeks a Director, Clinical-Translational Science to lead scientific direction across biobanking and translational research, aligning with clinical development objectives.

The role provides oversight for sample processing, storage, data management, and analyses, ensuring quality, safety and regulatory compliance, and collaborates with cross-functional teams and external partners to identify novel biomarkers and translational opportunities.