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Senior Molecular Biologist
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We are seeking a highly skilled Senior Molecular Biologist to lead the development of molecular diagnostic biomarker tests for early cancer detection at Lucid Diagnostics.
Key Responsibilities- Design, develop, and optimize genetic molecular diagnostic assays for early cancer detection, including biomarker discovery, assay validation, and clinical performance evaluation.
- Develop innovative approaches to enhance the sensitivity, specificity, and robustness of diagnostic tests, ensuring alignment with regulatory requirements.
- Conduct and oversee experiments to evaluate the feasibility and effectiveness of new molecular diagnostic technologies.
- Manage multiple R&D projects simultaneously, ensuring timely completion of milestones and objectives.
- Collaborate with cross-functional teams including bioinformatics, clinical lab, clinical research, quality & regulatory affairs, and product development to advance diagnostic test development from bench to bedside.
- Prepare and present detailed project plans, reports, and scientific publications to internal and external stakeholders.
- Mentor and provide scientific guidance to junior scientists and research associates, fostering a collaborative and innovative research environment.
- Stay abreast of the latest scientific and technological advancements in cancer diagnostics and molecular biology and integrate new knowledge into ongoing projects.
- Communicate complex scientific concepts clearly and effectively through oral presentations and written reports.
- Ensure that all research activities comply with relevant regulatory standards, including CLIA, CAP, and FDA guidelines for diagnostic test development.
- Write Standard Operating Procedures (SOPs), validation plans and reports as per regulatory standards.
- Contribute to the preparation of regulatory submissions, including material for FDA meetings and premarket approval (PMA) submissions.
- Participate in the strategic planning of the company's diagnostic product pipeline, providing insights into emerging trends and potential opportunities in the field of cancer diagnostics.
- Engage with key opinion leaders (KOLs), collaborators, and industry partners to establish and maintain strong scientific networks.
- Ph.D. in Molecular Biology, Genetics, Cancer Biology, or a related field.
- A minimum of 7-10 years of postdoctoral experience in molecular diagnostics, oncology, or a closely related area.
- Extensive experience in developing genetic assays, including qPCR, NGS, and other molecular techniques.
- Strong understanding of cancer biology, tumor genomics, and biomarkers relevant to early cancer detection.
- Proven experience in genetics, proteomics, epigenetics research related to cancer diagnostics.
- Track record of leading successful R&D projects, with a portfolio of peer-reviewed publications and patents.
- Experience with regulatory standards for diagnostic test development, including CLIA, CAP, and FDA regulations.
- Excellent leadership, communication, and project management skills.
- Ability to work effectively and collaboratively with multi-disciplinary teams.