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14 часов 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/Oncology): Leading first-in-human through phase 4 clinical trials, CRO oversight, budgets, timelines, and cross-functional execution with an accent on oncology therapeutics, operational strategy, and GCP-compliant trial delivery. 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 and 30% flexible work model

Salary: $142,500–$256,500 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA-based therapeutics and vaccines using its mRNA technology, delivery, and manufacturing platforms.

What you will do

  • Lead clinical trials from first-in-human through Phase 4 across the therapeutics and oncology portfolio.
  • Develop clinical operations strategies and plans aligned with clinical development programs.
  • Manage study budgets, timelines, resources, invoices, forecasting, and operational risks.
  • Select and oversee CROs, vendors, clinical sites, and outsourced trial activities.
  • Collaborate with Clinical, Regulatory, CMC, Biostatistics, Data Management, Finance, and Program Management teams.
  • Provide oversight and mentorship to Clinical Trial Managers and Clinical Trial Associates.

Requirements

  • BA/BS degree and 8–10 years of clinical trial or clinical program experience, including at least 4 years of independent trial management.
  • Full clinical trial lifecycle experience, including start-up, conduct, and closure.
  • Robust therapeutics and oncology experience; early clinical development and immuno-oncology experience are desirable.
  • Experience with GCP inspections, audits, clinical documents, operational compliance, and regulatory requirements.
  • Strong leadership, communication, organizational, collaboration, and problem-solving skills in biotech or pharmaceutical environments.
  • Some travel is required.

Nice to have

  • Advanced degree.
  • Experience with hematologic malignancies.
  • Experience building relationships with key opinion leaders.

Culture & Benefits

  • Competitive healthcare and voluntary benefit programs.
  • Fitness, mindfulness, and mental health resources.
  • Family planning support, including fertility, adoption, and surrogacy benefits.
  • Paid vacation, volunteer days, sabbatical, recharge days, and year-end shutdown.
  • Savings and investment programs plus location-specific benefits.
  • In-person collaboration supported by a 70/30 work model.

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