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2 дня назад

Sr. Manager, Clinical Management, Early Phase: Immunology/Auto-immune

150 034 - 224 250$
Формат работы
remote (только USA)
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
Sr. Manager, Clinical Management, Early Phase: Immunology/Auto-immune (Clinical Trials): Overseeing the planning, execution, and completion of early-phase immunology and autoimmune clinical studies with an accent on regulatory compliance, CRO and vendor management, and study budget control. Focus on managing complex First-in-Human SAD/MAD/POC trials, maintaining data integrity and TMF readiness, and coordinating cross-functional risk mitigation.

Location: Remote within the United States; travel up to 25% may be required.

Salary: $150,034–$224,250, plus incentive opportunity.

Company

hirify.global Pharmaceutical Companies develops and commercializes pharmaceutical products, including therapies in immunology and autoimmune indications.

What you will do

  • Oversee the planning, execution, and completion of early-phase clinical trials in compliance with regulations, ICH/GCP guidelines, and company SOPs.
  • Contribute to clinical protocols, informed consent forms, and other critical study documents.
  • Evaluate and oversee CROs, external service providers, central laboratories, IRBs, technology vendors, and investigative sites.
  • Lead clinical teams and coordinate study activities across internal departments, CROs, vendors, and sites.
  • Monitor study budgets, forecasts, resources, timelines, data integrity, and protocol compliance.
  • Support inspection readiness, TMF quality, risk mitigation, standardization, and continuous improvement initiatives.

Requirements

  • Ability to oversee complex First-in-Human SAD/MAD/POC trials, including basket trials, in immunology and autoimmune indications.
  • Comprehensive knowledge of clinical operations, drug development, SOPs, GCP, ICH, and global regulatory requirements.
  • At least 10 years of industry experience, including 7 years in clinical trial management.
  • Bachelor’s degree or Registered Nurse qualification.
  • Experience managing CROs, outsourcing activities, vendor statements of work, and clinical trial software such as eCRFs, IRT, and CTMS.
  • Strong communication, organization, planning, analytical, problem-solving, and people-management skills.

Nice to have

  • Previous supervisory experience.
  • Experience with Microsoft Word, Excel, PowerPoint, and Outlook.

Culture & Benefits

  • Full-time employment with flexible time off, paid holidays, and paid leave programs.
  • Medical, dental, vision, and prescription drug coverage.
  • Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
  • Tuition reimbursement and student loan assistance.
  • Generous 401(k) matching program.

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