About the role
The Clinical Lead, Partnership will define and drive clinical strategy for diagnostic product development within multi‑stakeholder collaborations, translating clinical insights into product specifications, guiding study design, and ensuring regulatory alignment.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Lead clinical input and strategy across partnered diagnostic development programs from concept through validation and implementation
- Identify and scope companion diagnostics partnership opportunities and engage biotech and pharma partners
- Engage clinical, academic, and industry partners to uncover unmet needs and translate them into Target Product Profiles and performance specifications
- Review, interpret, and integrate disease‑specific and diagnostic guidelines to define use cases and clinical utility frameworks
- Advise on clinical study design, endpoints, and patient selection criteria for product development and regulatory submissions
- Coach and mentor internal partnership, technology, and QA/RA teams to align clinical strategy with product and partnership goals
Requirements
- PhD in Clinical Sciences, Medicine, or related biomedical field or a Medical Degree (MD/MBBS) from a recognized university
- Minimum 10 years of experience in a clinical leadership role within diagnostics or pharmaceutical development
- Proven ability to translate clinical insights into actionable product development specifications
- Experience designing and developing companion diagnostics
- Deep understanding of diagnostic development lifecycles, including analytical and clinical performance evaluation, validation studies, and evidence generation
- Practical knowledge of international regulatory frameworks governing diagnostic products (e.g., HSA, FDA, IVDR, NMPA)