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5 дней назад

Senior Director, Patient Safety (MD) (Oncology)

255 425 - 330 550$
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
Senior Director, Patient Safety (MD) (Oncology) (Pharmacovigilance): Leading global medical safety strategy for oncology and immunology products, including surveillance, aggregate review, risk management planning, and regulatory engagement with an accent on safety signal assessment and product-focused pharmacovigilance. Focus on evaluating clinical and observational data, shaping regulatory decisions, managing safety risks, and leading process improvements under FDA and EU pharmacovigilance guidance.

Location: Parsippany, New Jersey, United States

Salary: $255,425–$330,550 per year for other U.S. locations. Bay Area range: $281,010–$363,660 per year.

Company

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

What you will do

  • Provide medical strategy and safety input for regulatory decisions, advisory panels, and stakeholder meetings.
  • Lead pharmacovigilance strategy for assigned products or therapeutic areas, including surveillance, aggregate review, and risk management planning.
  • Identify and assess safety signals and trends with drug safety risk management teams.
  • Lead product-focused safety activities and communicate key findings to senior management.
  • Drive process changes, SOP updates, audits, data analysis, and initiatives based on GVP and regulatory guidance.
  • Provide strategic input to mitigate pharmacovigilance-related risks.

Requirements

  • MD degree or equivalent, board eligible, with 12 years of relevant experience.
  • At least 8 years of drug safety, pharmaceutical industry, or clinical practice experience with extensive pharmacovigilance expertise.
  • Significant knowledge of EU and FDA pharmacovigilance guidelines, GCP, and clinical research methodology.
  • Strong leadership, problem-solving, negotiation, organization, planning, and communication skills.
  • Scientific, clinical, and analytical expertise, including the ability to assess data and medical safety implications.
  • Understanding of pharmacoepidemiology and the ability to critically evaluate observational studies; proficiency with Microsoft Word, Excel, and PowerPoint.

Nice to have

  • Board certification.
  • Oncology or immunology experience.
  • CAR T experience.

Culture & Benefits

  • People leadership focused on inclusion, talent development, and team empowerment.
  • Medical, dental, vision, and life insurance plans.
  • Paid time off and potential eligibility for an annual bonus.
  • Potential eligibility for discretionary stock-based long-term incentives.

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