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6 дней назад

Associate Director, Clinical Trial Operation (Biotech)

164 000 - 213 000$
Формат работы
remote (Global)
Тип работы
fulltime
Грейд
director
Английский
b2
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 Trial Operation (Biotech): Leading phase I-IV clinical trials from protocol concept through Clinical Study Report with an accent on cross-functional study leadership, vendor oversight, data quality, and patient-centric execution. Focus on applying risk-based quality management, integrating digital health and eClinical technologies, and managing complex global trials within budget and regulatory requirements.

Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 25% is expected for team meetings, events, and other business needs.

Salary: $164,000–$213,000 annual

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

  • Lead and oversee phase I-IV clinical trials from protocol concept through Clinical Study Report.
  • Establish and lead cross-functional Clinical Study Teams, including CTMs, CTAs, CROs, laboratories, sites, and other vendors.
  • Manage trial execution, timelines, budgets, metrics, KPIs, risk management, and vendor performance.
  • Create, review, and approve study documents, training materials, operational manuals, and study plans.
  • Apply Risk-Based Quality Management principles to protect data integrity and patient safety.
  • Drive the adoption of digital health and eClinical technologies and champion patient-centric trial design.

Requirements

  • Bachelor’s degree in life sciences, healthcare, or a related field.
  • 7+ years of clinical trial management experience with a sponsor company across multiple clinical phases.
  • Experience conducting global clinical trials across multiple therapeutic areas.
  • Experience managing clinical trial budgets, forecasting, accruals, invoicing, CROs, vendors, and laboratories.
  • Excellent written and verbal communication, critical thinking, organization, problem-solving, collaboration, and leadership skills.
  • Ability to work in compliance with ICH GCP and relevant regulatory guidelines.

Nice to have

  • Experience with rare diseases or orphan indications.
  • Experience managing a development program and participating in NDA or sNDA filings.

Culture & Benefits

  • Fully remote work with connection to the hirify.global team and community.
  • Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
  • 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
  • Learning programs, mentorship, employee resource groups, recognition programs, and volunteer opportunities.

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