Product Science, Associate Director - Immune Oncology

Organization
Genomic Health
Job Location
Apply Online
Redwood City, CA 94063
Job Description

Genomic Health is seeking a highly motivated, talented and collaborative scientist for the development of immune-oncology diagnostic products. This position plays a key leadership role in bringing new products and services to physicians which will help inform treatment decisions for patients with cancer. The Immune-Oncology Associate Director, will be responsible for R&D cross functional leadership in a matrixed environment whilst also providing scientific and technical expertise. The ideal candidate will be an expert in immunology and immune-oncology and have a proven track record in working collaboratively to deliver high quality results under aggressive timelines.

 

The position will report to the Senior Director, Genomic Sciences, within the R&D organization.

  • Provide leadership for assay development of immune-oncology diagnostic products.
  • Member of product program Core Team with the following accountabilities:
    • Participate in defining assay development and validation strategy.
    • Lead activities in new product research and development from investigation through validation and commercialization; produce data and documentation to support product requirements and development of intellectual property and product marketing materials.
    • Collaborate closely with functional area leads and Core Team members, including Process Engineering Lead, Product Lifecycle Manager, Program Manager, Clinical Lead and Commercial Lead to transform strategy into action and execution.
    • Direct liaison between the Core Team, Development Subteam(s) and Product & Services R&D functional group.
    • Understand and communicate the external trends affecting the program, especially scientific and technological, to influence plans for growth, product iteration and integration.
    • Develop external relationships.
  • Lead Development Subteam(s) with the following accountabilities:
    • Accountable for the overall assay product development and validation plans and execution, intellectual property, system design, readiness and transition from Development to Commercial and Lab Operations.
    • Identify needs of the Development Subteam(s) and partner with functional area groups for allocation of people and resources as required.
    • Accountable for assay development from investigation through validation and transfer in line with budget and timeline.
  • On Core and Subteams, provide subject matter expertise (biology, technology, process, genomics, etc.) directly, or identify a subject matter expert within the Products & Services R&D group to consult with the team as needed.
  • Accountable for documentation, execution, analysis and interpretation for a wide range of studies, including feasibility, exploratory, assay development and analytical validation.
  • May assess collaboration opportunities for biological fit, sample appropriateness, technical feasibility, etc.
  • Support Translational Sciences, Medical Affairs and Marketing in providing external scientific education on our products and technology to physician audiences.
  • Provide internal education about our products and technology to new and existing employees at varied experience and technical knowledge levels.
  • Provide scientific input to influence product and process improvements.
  • Accountable for writing scientific abstracts and publications pertaining to assay development and validation.
  • Apply the best principles of CLIA, GCP and design controls to product development as appropriate.
  • This is currently an Individual Contributor role performing in a team leadership capacity as a member of a Program Core Team and leader of relevant Development Sub-team(s).
  • Other responsibilities as assigned.



QUALIFICATIONS:

 

REQUIRED

  • PhD degree in a life science and 8+ years of relevant experience, preferably in diagnostics. Additional relevant experience may be considered in lieu of a PhD.
  • Broad experience in immunology, immune-oncology and cancer molecular genetics.
  • Broad understanding and experience in Next Generation Sequencing or Polymerase Chain Reaction.
  • Track record of success in motivating and leading cross-functional teams
  • Scientific and business acumen leading to data-driven decisions.
  • Demonstrated excellent oral, written and presentation-based communication and influencing skills.
  • Ability to manage dynamic projects and programs and to prioritize and drive to results with a high emphasis on quality.
  • Able to integrate and apply feedback in a professional manner.
  • Demonstrated ability to be highly effective in a fast-paced, rapid growth environment and strong team player.
  • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
  • Able to integrate and apply feedback in a professional manner.
  • Ability to work as part of a team.

 

 

DESIRED

  • Broad experience in tissue-based and liquid-based methods for evaluating tumor-associated biology.
  • Broad experience in cancer molecular genetics, with specific knowledge in one or more of breast cancer, prostate cancer, lung cancer and colon cancer and successful development of products in one or more of these areas.
  • Previous experience in developing and launching Lab Developed Tests under CLIA, or previous IVD development experience.



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