Exciting opportunity for an experienced, commercially orientated and ambitious Principal ScientistASX-listed biotechnology company with a broad cancer diagnostics pipelineSalary negotiable, depending on experienceFull-time position in MelbourneINOVIQ Ltd (ASX:IIQ) is a biotechnology company developing next-generation diagnostics and therapeutics for cancer. Our diagnostics portfolio utilises proprietary exosome and glycomic technologies to develop blood tests for earlier detection, treatment selection and monitoring of cancer to improve patient outcomes.Position Overview We are seeking a highly motivated Principal Scientist to join our collaborative and commercially focused R&D team. The Principal Scientist - Diagnostics will lead INOVIQ's diagnostics program to translate our cutting-edge technologies into clinically and commercially relevant products. The successful candidate will play a pivotal role in advancing our novel diagnostic tests from biomarker translation through validation to registration. You will have a proven track record in scientific leadership with expertise in development and validation of in vitro diagnostics for early detection, treatment selection and/or monitoring of disease to improve patient outcomes. If you have a passion for translating scientific innovations into impactful products, this opportunity is for you. Key responsibilities include planning, executing, and reporting on INOVIQ diagnostic programs in alignment with global quality and regulatory requirements to achieve R&D objectives.Responsibilities Provide leadership of INOVIQ diagnostics programs to develop clinically and commercially viable products that have a meaningful impact for patients, clinicians, and healthcare.Plan, manage, execute, and report on biomarker discovery, analytical and clinical validation studies for in vitro diagnostics to meet agreed technical, development and registration milestones on time and within budget.Ensure the maintenance of accurate laboratory records to secure intellectual property and document design control in accordance with regulatory guidelines.Manage external projects with diagnostics collaborators, partners, contract research/manufacturing organisations and consultants to meet agreed timelines, budgets, and outcomes.Perform and report data analyses of biomarker and assay performance using relevant statistical packages.Identify and evaluate new diagnostic technologies and product opportunities.Supervise, train and manage the diagnostics team.Liaise with regulatory consultants and agencies to ensure alignment with global LDT and IVD requirements.Essential Criteria PhD in Molecular and Cell Biology, Biochemistry, Genetics, Endocrinology, Immunology, or another relevant field.Minimum 5+ years of relevant laboratory research experience including 3+ years as a principal scientist working in a pharmaceutical or diagnostics industry setting with responsibility for diagnostics development.Proven track record in clinical diagnostics development including biomarker discovery, analytical validation, clinical validation of in vitro diagnostics for Oncology, or other relevant area.Significant research management experience with responsibility for design and execution of research plans, statistical data analysis and interpretation, progress reporting, and preparation of technical reports, publications and presentations on research findings.Knowledge of immuno- and molecular diagnostic development, standard diagnostic instrument platforms and IVD medical device regulatory requirements.Strong planning, critical thinking, and analytical skills with ability to solve specific research questions and technical issues.Broad knowledge of omics techniques across proteomics, glycomics and genomics technologies and application to biomarker discovery and diagnostics translation to clinically and commercially relevant products.Demonstrated knowledge of quality, regulatory, and safety standards for laboratories and GMP regulations including ISO17025 / ISO13485/ 21 CFR 820 and IVDR 2017/246.Strong interpersonal, communication and presentation skills with ability to communicate both orally and in writing.How to Apply: Interested candidates can apply by submitting your resume and cover letter outlining your relevant experience and qualifications to ****** by 1st May 2024. For further information, please contact Dr Ramin Khanabdali on +61 3 9548 7586.Please Note: Only shortlisted candidates will be contacted.
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