Principal Scientist, Oncology R&D

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

We are seeking a Principal Scientist, Oncology R&D to provide scientific leadership and drive the execution of research and development programs supporting our growing oncology portfolio. Reporting to the Senior Director, Oncology Diagnostics, this individual will serve as a senior technical expert responsible for advancing new and existing commercial laboratory-developed tests from concept through validation, regulatory submission, and clinical implementation.

The role spans assay development, biomarker research, validation strategy, technology development, and scientific program leadership, while remaining deeply engaged in laboratory operations and technical execution. This individual will lead complex cross-functional initiatives, provide scientific direction to project teams, and mentor junior scientists and research assistants without formal people management responsibilities.

The ideal candidate is an accomplished molecular diagnostics expert with extensive experience in NGS- and gene expression-based assays, a strong understanding of CLIA/CAP/NYS regulatory requirements, and a passion for developing innovative diagnostic solutions that improve patient care.

This is an onsite role in San Diego, CA.

Responsibilities

• Lead the 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 research studies on large patient cohorts to validate proprietary biomarkers and support product development objectives.
• Design and execute analytical and clinical validation studies for novel or modified assays, and prepare supporting documentation for regulatory submissions (e.g., NY/CLEP, MolDx, CAP).
• Lead exploratory research initiatives and investigational studies in collaboration with clinical development teams, external investigators, and key scientific partners.
• Serve as a subject matter expert to Quality, Regulatory, Clinical, and CLIA teams, providing technical guidance on protocols, design reviews, change controls, assay modifications, and compliance requirements.
• Lead multidisciplinary project teams to achieve program milestones, identify and mitigate technical risks, and drive successful execution across the product development lifecycle.
• Establish and optimize new technologies, methodologies, and workflows to support future diagnostic products and platform enhancements.
• Supervise, coach, and mentor junior scientists, research associates, and laboratory personnel, fostering scientific rigor and technical excellence.
• Communicate scientific findings, project updates, and strategic recommendations to internal and external stakeholders.
• Collaborate across R&D, Clinical, Regulatory, Quality, Biostatistics, and Operations teams to support organizational objectives and accelerate program delivery.

Qualifications

• Ph.D. in Molecular Biology, Genomics, Cancer Biology, Biomedical Sciences, or a related scientific discipline with 5+ years of relevant industry experience, preferably within a CLIA laboratory environment.
• Deep expertise in genomic and molecular diagnostics, including biomarker discovery, assay development, next-generation sequencing, gene expression technologies, and oncology applications.
• Demonstrated success leading complex scientific programs and cross-functional initiatives from concept through validation, transfer, and commercialization.
• Extensive experience developing Laboratory Developed Tests (LDTs), including feasibility assessment, assay development, analytical validation, product transfer, and launch activities.
• Strong knowledge of CLIA, CAP, NYS/CLEP, and related regulatory requirements governing molecular diagnostic testing.
• Proven ability to independently design experiments, interpret complex datasets, solve technical challenges, and drive scientific decision-making.
• Experience providing scientific leadership, supervision, and mentorship to junior scientists and research personnel without direct management authority.
• Exceptional organizational and project leadership skills, with the ability to manage multiple priorities and drive results in a fast-paced environment.
• Strong communication, presentation, technical writing, and interpersonal skills, with the ability to effectively engage cross-functional and external stakeholders.

The annualized base salary range for this role is $134,400 - $223,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans