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21 час назад

Associate Director, Clinical Operations (Therapeutics/Oncology)

142 500 - 256 500$
Формат работы
hybrid
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
Associate Director, Clinical Operations (Therapeutics/Oncology) (Clinical Trials): Leading first-in-human through phase 4 oncology clinical trials, CRO oversight, operational strategy, budgets, timelines, and cross-functional execution with an accent on trial quality, GCP compliance, and early clinical development. Focus on solving site activation, enrollment, monitoring, protocol deviation, inspection readiness, and vendor management challenges while mentoring clinical operations staff.

Location: Cambridge, Massachusetts, United States; 70% in-office work model. Due to U.S. export control requirements, only U.S. persons are eligible, and hirify.global cannot sponsor non-U.S. persons for an export control license.

Salary: $142,500–$256,500 annually, with potential bonus, incentive compensation, or equity award.

Company

hirify.global develops medicines using an mRNA technology platform and focuses on transforming how medicines are created and delivered.

What you will do

  • Lead and oversee oncology clinical trials from first-in-human through phase 4 across the full study lifecycle.
  • Develop clinical operations strategies and plans aligned with clinical development programs.
  • Manage study budgets, invoices, timelines, resources, forecasting, CROs, vendors, and site feasibility activities.
  • Coordinate cross-functional teams and provide operational input into protocols, regulatory documents, clinical study reports, and related plans.
  • Ensure GCP, regulatory, SOP, audit, inspection-readiness, and sponsor-oversight compliance.
  • Represent Clinical Operations with investigators, sites, key opinion leaders, vendors, and senior management while mentoring Clinical Trial Managers and Associates.

Requirements

  • BA/BS degree and 8–10 years of clinical trial and program experience, including at least 4 years of independent clinical trial management and full lifecycle delivery.
  • Robust therapeutics/oncology experience, with early clinical development and immuno-oncology experience desirable.
  • Experience developing operational solutions for site activation, enrollment, monitoring oversight, protocol deviations, and data cleaning.
  • Experience collaborating with Regulatory, CMC, Biostatistics, Data Management, Finance, and Program Management functions.
  • Experience with GCP inspections and audits, strong communication and organizational skills, and demonstrated leadership in multidisciplinary biotech or pharmaceutical teams.
  • Must qualify as a U.S. person under U.S. export control laws; visa sponsorship for non-U.S. persons is not available.

Nice to have

  • Advanced degree or experience in hematologic malignancies.
  • Established relationships with key opinion leaders.

Culture & Benefits

  • 70/30 in-office work model emphasizing collaboration, innovation, teamwork, and mentorship.
  • Healthcare coverage and voluntary benefits.
  • Fitness, mindfulness, mental health, and other well-being resources.
  • Family planning support, including fertility, adoption, and surrogacy benefits.
  • Paid time off including vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
  • Savings and investment programs, plus location-specific benefits.

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