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3 часа назад

Associate Director, Clinical Trial Disclosure & Transparency

Формат работы
hybrid
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US/Australia
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 Disclosure & Transparency (Clinical Research): Leading global clinical trial disclosure and transparency strategy across interventional and observational studies with an accent on regulatory compliance, public registry submissions, and redacted document packages. Focus on interpreting emerging regulations, managing vendors, guiding cross-functional stakeholders, and improving disclosure processes and metrics.

Location: King of Prussia, Pennsylvania, United States; hybrid work with 3 days in the office per week

Company

hirify.global Behring is a global biotherapeutics company developing therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas.

What you will do

  • Lead the global clinical trial disclosure and transparency strategy for interventional and observational studies.
  • Oversee study registrations, protocol amendments, results disclosures, and layperson summaries across public registries.
  • Support compliant redaction and anonymization packages for public release by health authorities.
  • Advise clinical, medical affairs, regulatory, legal, privacy, intellectual property, biostatistics, and medical writing stakeholders.
  • Select and manage disclosure and transparency vendors while improving processes, technology, resourcing, and operational efficiency.
  • Track compliance metrics, identify risks, and drive continuous improvement.

Requirements

  • 10+ years of experience in a pharmaceutical or biotech environment with deep knowledge of drug development.
  • Bachelor’s degree in a scientific, medical, or pharmaceutical discipline.
  • Experience managing global clinical trial disclosure and transparency deliverables and leading through influence in a matrix environment.
  • Strong ability to interpret emerging regulations, assess compliance risks, and provide practical recommendations.
  • Understanding of ICH-GCP, ICMJE, GDPR, and industry best practices.
  • Hands-on experience administering TrialScope Disclose or an equivalent system.

Culture & Benefits

  • Work within a global organization employing 32,000 people and serving patients in more than 100 countries.
  • Collaborate across a diverse, cross-functional biotherapeutics environment.
  • Benefits are provided through hirify.global’s employee well-being program.
  • hirify.global promotes inclusion, belonging, curiosity, and empathy.

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