The posting
The Clinical Lead will play a pivotal role in guiding the clinical strategy and direction for diagnostic product development programs driven by multi-stakeholder partnerships. This role bridges clinical insight with product innovation, ensuring that diagnostic solutions emerging from collaborative programs are clinically relevant, evidence-based, and aligned with global regulatory and guideline requirements.
Key Responsibilities
- Lead the clinical input and strategy across partnered diagnostic development programs, from early concept to validation and implementation.
- Lead scoping and identification of companion diagnostics partnership opportunities, as well as partnership engagement with biotech and pharma companies.
- Engage with clinical, academic, and industry partners to identify unmet clinical needs and translate these into Target Product Profiles (TPPs) and clinical performance specifications.
- Review, interpret, and integrate relevant clinical guidelines (e.g., disease-specific, diagnostic, or screening guidelines) to define use cases and clinical utility frameworks.
- Advise on clinical study design, endpoints, and patient selection criteria to support product development and regulatory submissions.
- Coach and mentor internal teams—including partnership, tech teams, QA/RA —to ensure alignment between clinical strategy, product requirements, and partnership goals.
- Contribute to regulatory and ethics submissions related to diagnostic validation and clinical performance studies.
- Represent the organization in external meetings, working groups, and consortium activities that advance diagnostic development and clinical adoption pathways.
Requirements
- PhD in Clinical Sciences, Medicine, or related biomedical field or a Medical Degree (MD/MBBS) from a recognized university.
- Minimum 10 years’ experience in a clinical leadership role within a diagnostics or pharmaceutical development environment.
- Demonstrated ability to translate clinical insights into actionable product development specifications.
- Experience in design and development of companion diagnostics.
- Deep understanding and experience in diagnostic development lifecycles, including analytical and clinical performance evaluation, clinical validation studies, and evidence generation.
- Practical knowledge of international clinical and regulatory frameworks governing diagnostic products (e.g., HSA, FDA, IVDR, NMPA).
- Excellent communication and stakeholder management skills with experience engaging clinicians, researchers, regulators, and industry partners.
- Experience leading clinical programs in genomics, molecular diagnostics, or infectious disease testing.
- Familiar with health economics, clinical utility studies, or clinical implementation pathways.
- Proven record of contributing to cross-sector partnerships or consortium-based R&D initiatives.
Leadership skills
- Strategic thinker with the ability to translate clinical knowledge into business growth and impact.
- Strong leadership and team-building skills with the ability to inspire and guide a diverse team of medtech professionals
- Excellent communication and presentation skills, with the ability to effectively convey complex medical information to diverse stakeholders.
- Strong professional relationships with key opinion leaders in practicing in key clinical areas including cancers, metabolic diseases, infectious diseases, mental health and population health in Singapore and globally.
- Business acumen and strategic thinking to drive the DxD Hub's clinical initiatives.
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
