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Clinical Development Consultant (Temporary Contract role)

Location: Redwood City
Posted on: November 11, 2018

Job Description:

Company Description ?ABOUT?OUR COMPANYGuardant Health is a pioneer in non-invasive cancer diagnostics and the first company to?commercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate and precise picture of the individual genomic alterations that cause tumors to grow, change, and develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, and our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development and improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish and new uses of our platform are emerging.We succeed best by coordinating our creative talents and energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.Job Description ?We?re looking for a consultant or two to help establish our Clinical Development Department of Guardant Health?s Lunar team.?This will be a contract assignment for three to six months reporting directly to the General Manager & Chief Lunar Officer. You?ll be responsible for developing and realizing the strategy for creating the evidence that supports registration and ultimate reimbursement of our current and future liquid biopsy program in early-stage cancers.Essential Duties and Responsibilities

  • Assists in creating the clinical development strategy for current and planned diagnostics and leads a team that includes medical directors, clinical development operations, and biostatistics. Brings clinical perspectives to corporate strategy to ensure alignment with current and future medical need for patients living with or at risk for developing cancer.?
  • Responsible for the development of clinical research protocols, clinical study reports, and scientific publications. Reviews, interprets, and communicates strategy, progress, and emerging data of ongoing research projects within and outside the organization. Forecasts and executes on departmental budget and financial reporting.
  • Ensures that clinical trials are conducted according to good clinical practice and all applicable regulatory requirements, standard operating procedures, and other quality standards.
  • Helps with clinical content to regulatory documents (IDE, PMA).? Contributes to overall regulatory strategy for key engagements with health care authorities including the US Food and Drug Administration.
  • Partners with internal stakeholders from medical affairs, biostatistics, technology development, business development, marketing, and sales to ensure that Clinical Development activities are aligned with strategy and to support clinical alignment in activities developed by other departments. Provides clinical and strategic insight to partnership opportunities and execution of companion diagnostic programs.Qualifications ?Qualifications
    • Medical Doctor or non-US equivalent of MD degree or Pharm.D, board certified or board eligible in oncology or an oncology-related sub-specialty preferred.
    • Clinical experience and knowledge of the treatment of cancer patients, including the incorporation of biomarkers and precision diagnostics in clinical decision making.
    • Oncology clinical trial experience in pharmaceutical or diagnostics industry or commensurate academic experience.
    • Ability to develop and run a complex clinical research program independently, including the design, conduct, and reporting of clinical studies.
    • Demonstrated ability to understand and interpret the regulatory requirements under which medicines and/or medical devices are developed, reviewed, and supported.?
    • Direct experience interacting with health care authorities such as FDA, EMA, PMDA to support clinical trial development and regulatory approval of medicines and/or IVDs.
    • Track record of regulatory submission either in the diagnostics or pharmaceutical arena is preferred.
    • Demonstrated experience with good clinical practice and clinical operations.Additional Information ?All your information will be kept confidential according to EEO guidelines.

      Keywords: GUARDANT HEALTH, INC, San Francisco , Clinical Development Consultant (Temporary Contract role), Healthcare , Redwood City, California

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