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3 дня назад

Medical Director, Clinical Development (Women's Health)

204 100 - 347 300$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
c1
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
Medical Director, Clinical Development (Women's Health) (clinical trials and regulatory strategy): Designing and overseeing clinical research studies for new and marketed drugs with an accent on protocol development, medical monitoring, and interpretation of efficacy and safety data. Focus on leading global development plans, solving complex trial execution and regulatory challenges, and authoring submission documents and clinical study reports.

Location: Remote within the US; US and Puerto Rico residents only

Annual salary: $204,100–$347,300 USD

Company

hirify.global is a global healthcare company focused on women's health, biosimilars, and a diverse portfolio of health solutions.

What you will do

  • Lead or contribute to global clinical development plans and design patient-centered clinical trial protocols.
  • Oversee study execution, site selection, recruitment, data quality, protocol compliance, and issue resolution.
  • Provide medical monitoring and clinical input on study documents, safety reports, data reviews, and clinical study reports.
  • Develop clinical and regulatory strategies with regulatory affairs, biostatistics, safety, market access, and commercial partners.
  • Author and edit regulatory submissions, briefing packages, response documents, and submission dossiers.
  • Engage with investigators, thought leaders, patient advocacy groups, medical affairs, and commercial teams.

Requirements

  • MD, DO, or MRCP qualification.
  • 2–4 years of clinical development experience in a biotechnology or pharmaceutical setting.
  • Familiarity with ICH, GCP, clinical trial execution, and medical monitoring processes.
  • Strong ability to analyze clinical data, anticipate risks, and support regulatory strategy.
  • Ability to work independently, prioritize effectively, and lead matrixed teams through complex decisions.
  • Fluent written and spoken English; candidates must reside in the US or Puerto Rico.

Nice to have

  • Clinical experience in women's health, dermatology, or pediatric development.
  • Substantial clinical trial leadership or relevant academic research experience.

Culture & Benefits

  • Remote work arrangement within the US.
  • Retirement savings plan and paid vacation and holiday time.
  • Paid caregiver, parental, and medical leave.
  • Medical, prescription drug, dental, and vision benefits.
  • Travel may be required for clinical trials or external engagement.

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