Lead Molecular Diagnostics Scientist Oncology R&D (Onsite)

Hologic, Inc.; San Diego (CA); On-site; USD 134,000 - 224,000; Full time

Job summary

Hologic, Inc. is seeking a Principal Scientist, Oncology R&D to provide scientific leadership and drive execution of research and development programs for our oncology portfolio.

This onsite San Diego role leads assay development, biomarker validation, and regulatory strategy, while mentoring junior scientists and coordinating with cross-functional teams. You will design and validate molecular assays, oversee cross-functional studies, and contribute to regulatory submissions to bring innovative

Qualifications

• Ph.D. required in molecular biology, genomics, cancer biology, biomedical sciences, or related field.
• Deep expertise in genomic and molecular diagnostics, including biomarker discovery, assay development, NGS, gene expression, and oncology applications.
• Proven ability to lead complex scientific programs and cross-functional initiatives from concept through validation, transfer, and commercialization.
• Extensive experience developing Laboratory Developed Tests (LDTs) and regulatory submissions.

Responsibilities

• Lead design, development, validation, and transfer of molecular assays including gene expression and NGS-based LDTs for patient testing in a CLIA laboratory.
• Drive scientific and technical execution of clinical studies on large patient cohorts to validate biomarkers and support product development.
• Design and execute analytical and clinical validation studies for novel or modified assays and prepare regulatory documentation.
• Lead exploratory research initiatives with clinical development teams, external investigators, and partners.
• Serve as SME to Quality, Regulatory, Clinical, and CLIA teams, guiding protocols, change controls, and compliance.
• Lead multidisciplinary project teams to milestones and drive program delivery.
• Establish and optimize new technologies and workflows for future diagnostics.
• Mentor junior scientists and laboratory personnel.
• Communicate findings and strategic recommendations to stakeholders.
• Collaborate across R&D, Clinical, Regulatory, Quality, Biostatistics, and Operations to accelerate delivery.

Skills

Scientific leadership

Cross-functional collaboration

Mentorship

Communication

Education

Ph.D. in Molecular Biology/Genomics/Cancer Biology/Biomedical Sciences

Job description

Hologic, Inc. is seeking a Principal Scientist, Oncology R&D to provide scientific leadership and drive execution of research and development programs for our oncology portfolio.

This onsite San Diego role leads assay development, biomarker validation, and regulatory strategy, while mentoring junior scientists and coordinating with cross-functional teams. You will design and validate molecular assays, oversee cross-functional studies, and contribute to regulatory submissions to bring innovative