About the role
AI summarisedThe Clinical Lead plays 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.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Lead 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 with biotech and pharma companies.
- Engage with clinical, academic, and industry partners to translate unmet clinical needs into Target Product Profiles (TPPs) and clinical performance specifications.
- Review 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 (partnership, tech, QA/RA) to align clinical strategy with 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.
Requirements
- PhD in Clinical Sciences, Medicine, or related biomedical field OR Medical Degree (MD/MBBS) from a recognized university.
- Minimum 10 years’ experience in a clinical leadership role within diagnostics or pharmaceutical development.
- Demonstrated ability to translate clinical insights into actionable product development specifications.
- Deep understanding of diagnostic development lifecycles, including analytical/clinical performance evaluation and evidence generation.
- Practical knowledge of international clinical and regulatory frameworks (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.