NeoGenomics Laboratories-posted 3 months ago
Full-time • Senior
Aliso Viejo, CA
1,001-5,000 employees

NeoGenomics is looking for a Senior Director, R&D who wants to learn to continue to learn in order to allow our company to grow. This is an onsite position working out of the Aliso Viejo, CA laboratory with a Monday – Friday day shift. As the Senior Director you will provide scientific and organizational leadership in the development of next-generation sequencing clinical diagnostic assays for cancer patients with a focus on Hematological assays. You will work closely with the lab-based team throughout the stages of feasibility, validation, regulatory submissions, and iterative improvements throughout the product life cycle.

  • Ensure Product Development transpires under levels of design control and development process management appropriate for the end market regulatory environment.
  • Work closely with team members in designing complex NGS assays for clinical oncology.
  • Immaculate attention to detail in analyzing and interpreting NGS data.
  • Strengthens the team’s expertise in heme cancers.
  • Provide leadership and oversight in producing appropriate validation packages for high throughput clinical NGS labs.
  • Presents data and project updates to cross-functional team. Be a driver in aligning the teams to make progress.
  • Prepares high quality technical reports including validation plans, validation reports, reimbursement submission packages.
  • Plan, prepare and produce posters, publications, management presentations.
  • Ability to work in a fast-paced, multi-tasking environment whilst maintaining quality scientific work.
  • PhD in genomic science and related field required.
  • A minimum of 12 years’ experience in NGS assay development clinical diagnostics.
  • Successful experience in heme assay development, validation and launch.
  • Successful experience in regulatory submissions to MolDx and New York State.
  • Experience in team management.
  • Experience in developing assays under design control and work in cross-functional environment.
  • Experience in developing assays for minimal residual disease (MRD) is highly desirable.
  • Whole Genome Sequencing assay development experience desirable.
  • Highly competitive benefits with a variety of HMO and PPO options.
  • Company 401k match.
  • Employee Stock Purchase Program.
  • Tuition reimbursement.
  • Leadership development.
  • 16 days of paid time off plus holidays.
  • Wellness courses.
  • Highly engaged employee resource groups.
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