Назад
Company hidden
9 дней назад

Senior Director of Clinical Operations

Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Senior Director of Clinical Operations (Clinical Trials/Biotech): Owning clinical and regulatory delivery for a Phase 2 trial from start-up through close-out, with an accent on safety, quality, risk-based oversight, and on-time, on-budget execution. Focus on making real-time clinical decisions, shaping portfolio-wide SOPs and trial systems, signing off essential trial documents, and guiding complex FDA-facing operations.

Location: Remote in the US

Company

Developing clinical-stage therapeutic assets through integrated, technology-first clinical trial infrastructure, with a focus on improving biopharma development.

What you will do

  • Own clinical and regulatory delivery for one in-licensed asset from trial start-up through close-out.
  • Ensure trial quality, safety, timeline, and budget performance while working closely with the Clinical Program Manager.
  • Identify and mitigate risks and contribute to the asset’s clinical development plan.
  • Shape Clinical Operations SOPs, processes, monitoring standards, oversight practices, and quality systems across the portfolio.
  • Advise on clinical delivery requirements for Citrus and other trial systems in partnership with Product and technology teams.
  • Provide portfolio-wide sign-off on safety, trial design, proportionality, essential documentation, and quality issues while mentoring the ClinOps team.

Requirements

  • 15+ years of clinical operations experience with hands-on delivery across multiple Phase 2 drug trials.
  • Experience with complex neurology trials in chronic indications, ideally Parkinson’s disease.
  • First-hand experience making clinical, quality, and safety decisions across multiple trials.
  • Senior review and sign-off experience for monitoring plans, RAMPs, protocol deviations, and eTMF readiness.
  • Experience designing SOPs and processes at portfolio or function level and influencing EDC, CTMS, and eTMF systems.
  • Experience across multiple regulatory jurisdictions; FDA experience is preferred.

Nice to have

  • Experience with FDA-facing clinical trials.
  • Experience in Parkinson’s disease trials.

Culture & Benefits

  • Mission-driven, high-growth, VC-funded startup environment.
  • Competitive salary and meaningful stock options.
  • 27 days of annual leave plus 11 national holidays.
  • US health insurance through TriNet, enhanced parental leave, and a monthly wellness allowance.
  • $2,000 annual learning and development allowance.
  • Remote team lunches, virtual and in-person company events, and access to gym and retail discounts.

Hiring process

  • Initial 30-minute conversation with a Senior Talent Partner.
  • Second interview with the VP Operations and another interviewer, followed by a functional interview with the CMO and Head of Quality.
  • Final 30-minute values interview with two team members.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →