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6 дней назад

Senior Clinical Trial Manager (Biotech)

180 000 - 220 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
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
Senior Clinical Trial Manager (Biotech): Leading the execution and operational management of global Phase 2/3 clinical trials for the MAR002 acromegaly program with an accent on study delivery, CRO and vendor oversight, enrollment, budgets, and regulatory compliance. Focus on managing cross-functional study teams, mitigating operational risks, supporting clinical trial documentation and submissions, and maintaining inspection readiness under ICH-GCP requirements.

Location: South San Francisco, United States; on-site at least three days per week

Salary: $180,000–$220,000 per year

Company

hirify.global is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine diseases, including MAR001 for severe hypertriglyceridemia and MAR002 for acromegaly.

What you will do

  • Lead the day-to-day execution, oversight, and delivery of clinical studies for the MAR002 program.
  • Manage the Study Management Team and coordinate cross-functional study execution across start-up, enrollment, maintenance, and close-out.
  • Oversee CROs and vendors, including vendor selection, contracts, work orders, performance indicators, and operational governance.
  • Identify study risks, implement mitigation plans, and support site engagement and subject recruitment strategies.
  • Contribute to trial design, study-level documentation, regulatory submissions, budgets, and operating plans.
  • Lead or support inspection readiness, clinical SOP development, and process improvement initiatives.

Requirements

  • BA/BS or higher degree in a relevant scientific discipline.
  • 6–9 years of clinical research or clinical operations experience in the pharmaceutical industry.
  • Global Phase 2–3 clinical trial experience.
  • Experience leading cross-functional study execution teams and managing CROs and vendors.
  • Strong communication, presentation, problem-solving, conflict management, organizational, and project execution skills.
  • In-depth knowledge of clinical research regulations and guidelines, including ICH-GCP, with the ability to work across multiple time zones.

Nice to have

  • Biotechnology or small-pharma experience.
  • Experience mentoring junior team members.

Culture & Benefits

  • Hands-on, collaborative environment where employees work directly across levels and functions.
  • Dynamic clinical-stage biotechnology setting with opportunities to support multiple development programs.
  • Occasional travel may be required to meet business objectives.
  • Role involves desk- and computer-based work, with occasional handling of objects weighing up to 20 pounds.

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