Senior Lead/ Senior Manager - J50963

Role & responsibilities

Key Responsibilities
Own the diagnostics pipeline end-to-endtimelines, milestones, risks, and resources from feasibility to launch.
Drive IVD kits through design transfer, verification and validation, and regulatory filings (CDSCO, CE-IVDR).
Build external partnerships with hospitals, labs, and KOLs to secure samples, run validations, demos, and studies.
Design and manage performance studies—protocols, site coordination, data analysis, and reports.
Coordinate across R&D;, Manufacturing, QA/RA, and Commercial to transparent bottlenecks and speed up decisions.
Build dashboards on pipeline status, timelines, and cost; flag risks early.
Run program reviews and prepare updates for leadership, partners, and funders.

Qualifications
Science background (must have): Bachelor’s or above in life sciences,



biotechnology, or molecular biology; Master’s or PhD preferred
5 - 8 years’ experience in molecular diagnostics kit development (IVD) and launch across Indian (CDSCO) and European (CE-IVD/IVDR) pathways is a MUST
Project management experience running multi-stakeholder programs to deadline in diagnostics or life sciences is a MUST
Working knowledge of clinical performance studies and ISO 13485 quality systems will be an added advantage
Excellent analytical skills; comfortable with data, timelines, and trade-offs
Confident in partner-facing roles; network with hospitals, labs, or CROs a plus
PMP certification will be an added advantage

📌 Senior Lead/ Senior Manager Bengaluru (India)
🏢 Sampoorna Consultants
📍 India