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Addis Ababa, Ethiopia

+251 72 313 3630

+251 91 131 3630

© 2026 Ethiopian Profiles. All rights reserved.

Dr. Tiruneh Hailemariam
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Dr. Tiruneh Hailemariam

Diagnostics Innovator | Precision Medicine & Biotech Expert | Clinical & Medical Affairs Leader
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Quick Insights

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Selected Career Milestones

Professional Experience Clinical & Medical Affairs Lead — Biocartis: Leading global clinical integration of precision medicine programs, diagnostic strategy, and medical affairs in oncology and infectious disease diagnostics. Senior Clinical Project Leader & Medical Affairs Roles — Biocartis / BD / Former R&D teams Held senior roles in diagnostic and R&D leadership, contributing to product development, clinical trials, and regulatory pathways for advanced diagnostic assays. Sr. Manager, Product Development / Senior Scientist Roles: Contributed across industry teams focusing on product innovation, clinical validation, and lifecycle management. Early Career — Research Fellow / Scientist Worked in molecular biology research and development, including positions at research centers and biotech labs, building strong foundations in lab science and translational research.

Professional Overview

Dr. Tiruneh Hailemariam is an experienced scientist and biotechnology expert with over 15 years of industry leadership in molecular and cellular biology, diagnostics innovation, and precision medicine. Born and raised in Ethiopia, he has built a global career spanning advanced diagnostic development, clinical validation, and biotech strategy.

He is currently Clinical & Medical Affairs Lead at Biocartis, where he guides precision medicine initiatives and the development of companion diagnostics for immunotherapies and targeted therapies. His expertise includes regulatory compliance, product development life cycles, and global clinical programs. Previously, he contributed to the development of the first FDA-approved molecular immunohematology assay, recognized among The Scientist Magazine’s Top Ten Innovations.

Dr. Tiruneh integrates scientific knowledge with business strategy, leadership, and translational research to advance healthcare diagnostics and clinical innovation globally.

Areas of Expertise

● End-to-end vitro diagnostic development ● Process Development and Quality Systems ● Clinical Trial Assays & Companion Diagnostics Strategies ● Clinical Development and Clinical Trial Operations (ICH-GCP) ● Clinical Trial & Medical Affairs Leadership. ● Global Regulatory Strategies, including US-FDA, EU-IVDR, and China ● Molecular and Cellular Biology ● Innovation & Technology Translation ● Precision Medicine and Translational Research ● Molecular diagnostics in oncology including colorectal cancer, breast cancer, lung cancer, and melanoma cancer.

Professional Services & Advisory

Consulting & Advisory Services Dr. Tiruneh is available for: ● Biotech innovation strategy ● Quality system development for diagnostic and drug development and manufacturing ● Clinical trials advisory ● Diagnostics laboratory and services development ● Precision medicine program design ● Regulatory strategy and submissions ● Diagnostic product development pathways ● Healthcare systems partnership planning Mentorship & Speaking Areas ● Precision Medicine & Diagnostics ● Biotech Product Lifecycle Leadership ● Translational Research Strategy ● Regulatory Science & Clinical Trials ● Healthcare Innovation in Emerging Markets

Beneficiaries & Engagement Focus

Ideal Engagement Partners ● Biotech including Diagnostics, drug, and Vaccine Development Companies ● Healthcare delivery systems (Hospitals and Clinical laboratories) ● Clinical research organizations ● Government health agencies ● Academic medical centers ● International health initiatives

Education

PhD in Molecular & Cellular Biology State University of New York (SUNY) — Downstate Medical Center MS in Molecular Biology University of North Carolina—Charlotte BS in Biological Sciences Alemaya University (Ethiopia)

Selected Publications, Awards & Legacy Achievements

Dr. Tiruneh was among the scientists who developed one of the first molecular immunohematology assays approved by the U.S. FDA, recognized as one of The Scientist Magazine’s Top Ten Innovations of the Year. His career bridges foundational science, product innovation, and clinical application. Dr. Tiruneh also led the clinical development of various companion diagnostics devices approved by global regulatory agencies for colorectal cancer and lung cancer.

Platform Acknowledgment

Ethiopian Profiles recognizes Dr. Tiruneh Hailemariam for outstanding contributions to their field and for demonstrating professional excellence that contributes to Ethiopia's knowledge and development.
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Last Updated: April 2026

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