Director, Oncology R&D

• →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

• 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.

If you have the right skills and experience, apply today!

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