Назад
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47 минут назад

Director, Clinical Management (Psychedelics)

186 489 - 278 875$
Формат работы
remote (только USA)
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, Clinical Management (Psychedelics) (Clinical Operations/Drug Development): Leading the operational strategy, planning, execution, and completion of global clinical programs with an accent on regulatory compliance, clinical trial quality, and cross-functional program leadership. Focus on developing clinical and regulatory documents, managing CRO partnerships and program risks, interpreting clinical data, and supporting psychedelic programs involving controlled substances.

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

Salary: $186,489–$278,875 per year, plus an incentive opportunity.

Company

hirify.global is a pharmaceutical company developing and commercializing medicines and conducting global clinical research.

What you will do

  • Lead the operational strategy and objectives of global clinical development programs in collaboration with senior clinical management.
  • Plan, execute, and complete clinical programs in accordance with GCP, ICH Guidelines, applicable regulations, SOPs, timelines, and budgets.
  • Lead program-level teams, advisory boards, cross-functional meetings, and clinical management representation for assigned programs.
  • Develop and maintain clinical and regulatory documents, including investigator brochures, briefing books, submission dossiers, and responses to health authorities.
  • Oversee clinical data review, final analysis, clinical trial reports, publications, inspection readiness, and risk mitigation activities.
  • Manage CRO and external service provider partnerships, support HEOR strategy, and contribute to portfolio resource planning.

Requirements

  • Bachelor’s degree and at least 14 years of applicable pharmaceutical industry experience, including 10 years of clinical trial management experience.
  • Previous supervisory experience and strong people management, communication, organization, planning, analytical, and problem-solving skills.
  • Comprehensive knowledge of clinical operations, drug development, SOPs, GCP, ICH regulations, global regulatory requirements, biostatistics, data management, and medical writing.
  • Thorough knowledge of CROs, outsourcing, vendor statements of work, and clinical trial implementation and management.
  • Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Outlook, plus familiarity with eCRFs, IRT, CTMS, and related clinical trial software.
  • Must be able to work remotely within the United States and travel up to 25%.

Nice to have

  • Advanced degree.
  • Experience with controlled substances.

Culture & Benefits

  • Medical, dental, vision, and prescription drug coverage.
  • Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
  • Tuition reimbursement and student loan assistance.
  • 401(k) match, flexible time off, paid holidays, and paid leave programs.
  • Equal opportunity employment and reasonable accommodation support for qualified applicants.

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