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5 дней назад

Director, Oncology R&D

161 800 - 287 700$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Director, Oncology R&D (Molecular Diagnostics/NGS): Leading the development, validation, transfer, and clinical implementation of oncology laboratory-developed tests with an accent on biomarker research, gene expression assays, next-generation sequencing, and regulatory submissions. Focus on directing large-cohort clinical validation studies, advancing diagnostic technologies, advising quality and regulatory teams, and mentoring research personnel.

Location: Onsite in San Diego, California, United States

Salary: $161,800–$287,700 annualized base salary; bonus eligible.

Company

hirify.global develops healthcare technologies and diagnostic solutions, including oncology diagnostics.

What you will do

  • Lead the scientific strategy and execution of oncology research and development programs.
  • Develop, validate, and transfer gene expression and next-generation sequencing laboratory-developed tests for patient testing in a CLIA laboratory.
  • Direct clinical research studies and analytical and clinical validation programs for proprietary biomarkers and new or modified assays.
  • Prepare technical documentation for regulatory submissions, including NY/CLEP, MolDx, and CAP requirements.
  • Provide technical guidance to Quality, Regulatory, and CLIA teams and communicate findings to internal and external stakeholders.
  • Manage and mentor research personnel while collaborating with clinical development, research investigators, and cross-functional teams.

Requirements

  • Ph.D. in a relevant scientific discipline and 5+ years of industry experience, preferably in a CLIA laboratory setting.
  • Expertise in genomic and molecular testing, biomarker assay development, next-generation sequencing, gene expression methodologies, and oncology applications.
  • Extensive experience developing laboratory-developed tests from concept and feasibility through analytical validation, product transfer, and launch.
  • Proven experience in a CLIA/CAP laboratory environment and familiarity with associated regulations.
  • Ability to independently plan and execute experiments, manage competing priorities, and lead research associates.
  • Strong communication, writing, presentation, and interpersonal skills for cross-functional collaboration.

Culture & Benefits

  • Comprehensive training is provided at onboarding.
  • Continued professional development and training are available throughout the career.
  • Bonus eligibility is included in the compensation package.

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