Director of Translational Diagnostics
MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.
Job Location: Helios
Job Summary
We are seeking an experienced and strategic Director of Translational Diagnostics to lead the end-to-end development and implementation of lab-developed tests (LDTs) and establish a new CAP- and MOH-compliant clinical diagnostics laboratory. This individual will play a pivotal role in bridging assay innovation with clinical utility, overseeing the development, validation, and manufacturing of diagnostic reagents, and provide technical support to overseas clinical labs.
Roles and Responsibilities
LDT Development and Validation
- Lead the design, development, and analytical validation of LDTs, including both molecular and non-molecular assays.
- Collaborate with bioinformatics, clinical, and regulatory teams to translate research findings into clinically actionable assays.
- Define and oversee study designs for assay verification and validation, aligned with CAP and MOH requirements.
Reagent Manufacturing and Assay Scale-up
- Oversee the design and production of LDT reagents, ensuring batch consistency, quality, and compliance with GMP-like standards where applicable.
- Work closely with clinical and quality teams to implement robust production and QC protocols for assay kits.
Technology and Clinical Lab Enablement
- Provide technical oversight during technology transfer, training, and assay onboarding processes in external sites.
- Ensure assay performance is consistent across multi-site implementations.
Laboratory Expansion and Certification
- Lead the planning, establishment, and certification of a new clinical diagnostics laboratory.
- Drive laboratory design, equipment selection, workflow setup, and quality system development to meet CAP and MOH standards.
- Work with regulatory and compliance teams to secure necessary licenses and certifications.
Strategic and Cross-functional Leadership
- Provide scientific and technical guidance to cross-functional teams including R&D, medical affairs, and commercial functions.
- Evaluate and integrate new technologies to enhance assay capabilities and laboratory scalability.
Desired Skills and Competencies
- PhD or equivalent in Molecular Biology, Clinical Diagnostics, Biomedical Sciences, or related field.
- At least 8 years of experience in diagnostics, with strong focus on LDT development and implementation.
- Proven experience in setting up or leading CAP- and/or MOH-certified labs is highly preferred.
- Strong knowledge of molecular diagnostics platforms (e.g., qPCR, NGS, miRNA, etc.).
- Familiarity with ISO 15189, CLIA, CAP, and local regulatory frameworks.
- Demonstrated leadership in cross-functional and cross-site project management.
- Excellent communication, stakeholder management, and technical writing skills.
Preferred Attributes
- Experience in diagnostic assay productization and/or commercialization.
- Experience in multi-site or international lab network implementation.
- Comfortable operating in a fast-paced, agile biotech environment.
This position is based in Singapore.
To submit your application, please send your resume to [email protected], quoting the Job title in the subject line.
We appreciate your interest in the above-mentioned position, however, due to overwhelming response, only shortlisted candidates will be contacted.
