US Early Access Programs Lead

Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield (CT); On-site; USD 166,000 - 248,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Retirement savings opportunities

Paid time off & holidays

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a US Early Access Program Manager to translate global EAT framework into coordinated U.S. execution.

The role spans across Medical Affairs, Regulatory, Patient Safety, Clinical Development, Quality, and supply, ensuring timely, inspection-ready delivery of EAP/OOS activities. The ideal candidate has 7+ years in pharma/clinical research with strong program management and regulatory knowledge, and the ability to lead complex cross-functional

Qualifications

• Bachelor's degree required in a related scientific, business, or clinical discipline; advanced degree preferred.
• 7+ years of relevant pharmaceutical industry and/or clinical research experience with program management exposure.
• Experience coordinating cross-functional programs from planning through implementation and closeout; expanded access, compassionate use, or patient-access services preferred.
• Familiarity with FDA expanded access regulations and ICH-GCP principles; knowledge of safety, quality, and regulatory interfaces.
• Strong governance, stakeholder management, and data-driven decision-making capabilities.
• Ability to lead complex programs across multiple functions and external vendors.

Responsibilities

• Lead centralized U.S. program management and operational enablement for EAP/OOS activities.
• Coordinate development and maintenance of implementation materials, training content, and escalation guidance.
• Provide support to Local EAP Coordinators and local TA OOS Leads; manage dependencies and timelines.
• Ensure compliance, quality, safety, and inspection readiness across EAP/OOS operations.
• Develop US operational reporting and drive continuous improvement in partnership with global teams.

Skills

Program management

Cross-functional collaboration

Regulatory knowledge

FDA regulations

Education

Bachelor's degree in related field

MA/MS/MBA preferred

Tools

BOOST

Veeva

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a US Early Access Program Manager to translate global EAT framework into coordinated U.S. execution.

The role spans across Medical Affairs, Regulatory, Patient Safety, Clinical Development, Quality, and supply, ensuring timely, inspection-ready delivery of EAP/OOS activities. The ideal candidate has 7+ years in pharma/clinical research with strong program management and regulatory knowledge, and the ability to lead complex cross-functional