Director, Oncology R&D

DIRECT SALES, US; San Diego (CA); On-site; USD 162,000 - 288,000; Full time

Job summary

Hologic, Inc. seeks a Director, Oncology R&D to lead scientific strategy and execution of our oncology diagnostic programs.

You will advance LDTs from concept through validation, regulatory submission, and clinical implementation, reporting to the Senior Director Oncology Diagnostics. This onsite role in San Diego requires deep molecular diagnostics expertise, including NGS- and gene expression-based assays, and a proven ability to develop and transfer assays within a CLIA framework while

Qualifications

• Ph.D. in a relevant discipline with 5+ years in industry, preferably CLIA lab.
• Extensive expertise in biomarker assay development, NGS, and gene expression in oncology.
• Experience in LDT development from concept to launch and regulatory submission.
• Familiarity with CLIA/CAP regulations and laboratory operations.
• Strong organizational, prioritization, and cross-functional collaboration skills.
• Excellent writing and presentation abilities to diverse stakeholders.

Responsibilities

• Develop, validate, and transfer molecular assays, including NGS-based LDTs.
• Lead clinical studies to validate proprietary biomarkers.
• Plan analytical/clinical validation and prepare regulatory documentation.
• Conduct exploratory research with clinical development and investigators.
• Provide SME guidance to QA, Regulatory, and CLIA teams.
• Mentor a team of research personnel in assay development.
• Communicate findings to internal and external stakeholders.
• Collaborate with cross-functional teams to meet goals.

Skills

Genomic testing expertise

Biomarker assay development

NGS-based assays

Team leadership

Regulatory knowledge (CLIA/CAP)

Cross-functional collaboration

Scientific communication

Education

Ph.D. in molecular diagnostics or related field

Job description

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

The role spans portfolio planning, lifecycle management of proprietary diagnostic tests, exploratory biomarker research, and establishing new technologies, while remaining deeply engaged in the laboratory and scientific details.

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 building innovative diagnostics that improve patient care.

This is an onsite role in San Diego, CA.

Responsibilities

• Develop, validate, and transfer molecular assays, including gene expression and NGS-based LDTs for patient testing in a CLIA laboratory
• Direct and drive clinical research studies on large patient cohorts to validate proprietary biomarkers
• Design and execute analytical and clinical validation studies for novel or modified existing assays, and prepare documentation for regulatory submission (e.g., NY/CLEP, MolDx, CAP)
• Execute exploratory research and investigational studies in collaboration with clinical development team and research investigators
• Provide technical advice and subject matter expertise to Quality, Regulatory and CLIA teams, including review of technical documents, protocols, design proposals, change requests, assay and procedural modifications
• Manage and mentor a team of research personnel engaged in assay development, clinical research, and product/process development
• Communicate research and development findings to internal and external stakeholders
• Collaborate with cross-functional teams to achieve departmental and organizational goals

Qualifications

• Ph.D. in a relevant scientific discipline, with 5+ years of industry experience, preferably in a CLIA laboratory setting
• Comprehensive knowledge of genomic and molecular testing, with demonstrated expertise in biomarker assay development, next-generation sequencing, gene expression methodologies, and their applications in oncology
• Extensive experience in Laboratory Developed Test (LDT) development, starting from product concept, feasibility, analytical validation, product transfer, and launch
• Proven track record working in a CLIA/CAP laboratory environment, and familiarity with associated regulations
• Exceptional organizational skills, with the ability to prioritize and manage multiple projects with competing deadlines
• Capable of independently planning and executing experiments, understanding project objectives, and leading a team of research associates
• Strong communication, writing, presentation, and interpersonal skills; able to collaborate effectively across diverse teams

The annualized base salary range for this hourly role is $161,800 - $287,700 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.