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2 дня назад

Director, Patient Safety (MD) (CAR-T)

221 000 - 286 000$
Формат работы
onsite
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, Patient Safety (MD) (CAR-T): Leading patient-safety strategy for CAR-T clinical development programs and postmarketing activities with an accent on signal detection, benefit-risk assessment, and regulatory compliance. Focus on authoring safety documentation, leading SRC and DSMB reviews, shaping risk-management strategies, and applying real-world evidence and advanced analytics.

Location: United States — New Jersey — Parsippany

Salary: $221,000–$286,000 per year, with potential annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing CAR and T-cell receptor engineered cancer immunotherapies.

What you will do

  • Lead safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.
  • Own safety strategy, patient risk-management activities, and safety communications for assigned products.
  • Author safety sections for protocols, Investigator’s Brochures, CSRs, DSURs, RMPs, and regulatory responses.
  • Represent Drug Safety on global development and product teams and lead SRC and DSMB meetings.
  • Collaborate with Clinical Research, Regulatory, Biostatistics, Medical Affairs, Pharmacovigilance, and external partners.
  • Drive safety-science innovation, process improvements, inspection readiness, and safety-operations planning while mentoring junior scientists.

Requirements

  • MD required; residency or subspecialty fellowship preferred.
  • At least 5 years of drug safety or pharmacovigilance experience focused on clinical trials and cross-functional collaboration.
  • Experience with cell or gene therapy, immunotherapies, or inflammation therapies.
  • Clinical experience in oncology, rheumatology, or neurology is strongly preferred.
  • Knowledge of global regulatory requirements, including FDA, EMA, and ICH.
  • Experience with safety databases and signal-detection tools such as ARISg, Argus, Empirica, or Spotfire.

Culture & Benefits

  • People-leadership responsibilities include creating inclusion, developing talent, and empowering teams.
  • Medical, dental, vision, and life insurance plans are available to eligible employees.
  • Paid time off and potential discretionary bonus and stock-based long-term incentives are offered.
  • Focus on scientific rigor, collaboration, employee development, and an inclusive work environment.

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