About the role
AI summarisedThe Clinical Lead drives clinical strategy and diagnostic product innovation through multi-stakeholder partnerships. This role bridges clinical expertise and technical development to ensure diagnostic solutions align with global regulatory standards and unmet medical needs.
ResearchOnsiteDiagnostics Development Hub
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 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.
- 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.
- Strong professional relationships with key opinion leaders practicing in key clinical areas including cancers, metabolic diseases, infectious diseases, mental health and population health.