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16 часов назад

Senior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology)

246 000 - 349 500$
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
Senior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology) (Clinical Compliance): Ensuring compliant clinical research execution across risk management, issue management, vendor oversight, site and data monitoring, and inspection readiness with an accent on ICH GCP, CAPA oversight, and cross-functional process standardization. Focus on designing risk and issue management frameworks, analyzing compliance trends, improving study execution, and coordinating with Quality Assurance and external suppliers.

Location: Remote within U.S. geographic markets; occasional travel to current or prospective vendor facilities may be required, at less than 10%.

Base salary: $246,000–$349,500 annually, adjusted according to geographic market, qualifications, experience, and internal equity.

Company

hirify.global is a biotechnology company developing therapies and conducting clinical research in oncology.

What you will do

  • Lead Clinical Operations risk and issue management to support compliant study execution.
  • Define the functional risk and issue management strategy, methodology, and annual plan.
  • Review monitoring outcomes, identify trends, and translate data into process improvements and risk-based decisions.
  • Support CAPA owners through assignment, follow-up, completion tracking, and leadership reporting.
  • Partner with Quality Assurance, Clinical Development, Data Management, R&D, and other functional teams.
  • Standardize cross-study processes, templates, systems usage, and inspection-readiness activities.

Requirements

  • Bachelor’s degree with at least 15 years of related experience, master’s degree with at least 13 years, doctoral degree with at least 12 years, or an equivalent combination.
  • Biotechnology or pharmaceutical industry experience is required, including experience with CROs, R&D outsourcing, purchasing, or procurement.
  • Senior-level team leadership and prior experience managing teams, consultants, or external suppliers.
  • In-depth knowledge of biopharmaceutical regulations, standards, best practices, and the relevant scientific, legal, and regulatory environment.
  • Strong leadership, communication, collaboration, analytical, strategic-thinking, problem-solving, change-management, and organizational skills.
  • Advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.

Culture & Benefits

  • Remote work with equipment including dual monitors and ergonomic chairs.
  • Medical, dental, vision, life, disability, and flexible spending account benefits.
  • 401(k) plan with company contributions and access to company stock and long-term incentives.
  • Discretionary annual bonus program.
  • Fifteen accrued vacation days in the first year, 17 paid holidays, a company-wide winter shutdown, and up to 10 sick days annually.

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