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GCO External Research

The Position

As the Global Capability Owner for Early Access Treatments (EAT), you will lead the strategic development, implementation, and continuous improvement of Boehringer Ingelheim’s EAT capability across global and regional teams. This role is pivotal in enabling access to investigational or unapproved medicines for patients with high unmet medical needs, ensuring compliance with global governance and regulatory standards.
You will serve as the single point of accountability for the EAT capability lifecycle—from strategy to execution—driving operational excellence, stakeholder alignment, and innovation in how Boehringer delivers compassionate use and expanded access programs.

This position can be filled in different countries:​

If you want to apply for the position in USA, please use this link: Sr. AD, Global Capability Owner - Early Access Treatments Job Details | BoehringerPRD 

If you want to apply for the position in Germany click "Apply now"

Tasks & responsibilities

  • Lead and evolve the EAT capability strategy globally, aligning with corporate objectives and regulatory frameworks (e.g., ICH-GCP, FDA, EU).
  • Champion the Global Out of Scope (OOS) Platform (for single named patient use) and oversee training, onboarding, and continuous improvement initiatives across regions. 
  • Develop and oversee standardized processes such as the global EAT SOP, Local Working Instructions as well as global and local How to Guides (HTGs) to support EAT implementation in local markets.
  • Manage cross-functional squads and collaborate with Pharmacovigilance, Regulatory Affairs, Brand Teams, IMP Delivery, Quality Medicine on global and local level, as well as IT to co-create channels and digital tools
  • Ensure compliance with pharmaceutical standards, ethics, and legal frameworks considering audit-/ inspection-readiness and metric-based evaluations.
  • Drive stakeholder engagement across global TAs, (R)OPUs, and external partners, to ensure timely and compliant EAT delivery. 

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Medicine, or related field; Project Management certification preferred.
  • Few years of experience in Medical Affairs or pharmaceutical industry, ideally with exposure to Post Trial Access, Early Access Treatments (incl. Expanded Access Programs (EAP), Compassionate Use Program (CUP) and Named Patient Use
  • Strong understanding of regulatory and compliance frameworks (FDA, EU, etc.).
  • Experience in project management, stakeholder coordination, and digital platform development.
  • Excellent communication skills and ability to navigate complex global environments.
  • Strategic mindset with a patient-centric approach and commitment to operational excellence.

Ready to contact us? 

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Apply now »