Job DescriptionWe 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.
If you have the right skills and experience, apply today!
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Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
