Early Access Programs Management

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

Job summary

Boehringer Ingelheim is seeking a U.S. Early Access Program Manager to translate the global EAT framework into coordinated U.S. implementation.

This role collaborates with Clinical Development, Regulatory Affairs, Patient Safety, Quality, and external partners to deliver timely, inspection-ready execution of EAP/OOS activities. The incumbent will lead centralized PM activities, support Local EAP Coordinators, and manage vendor relationships, while ensuring compliance with FDA expanded access

Qualifications

• Bachelor's degree in a related scientific, business, or clinical discipline; MA/MS/MBA preferred.
• 7+ years of pharma/clinical operations experience with program-management focus.
• Experience coordinating complex cross-functional programs from planning to closeout.
• Knowledge of FDA expanded access regulations and ICH-GCP principles.

Responsibilities

• Lead centralized U.S. program management and operational enablement for EAP/OOS activities with integrated plans and governance.
• Provide PM support to Local EAP Coordinators; coordinate workplans, documentation, and system setup.
• Support Local TA OOS Leads; ensure alignment with approved guidance and registry.
• Develop and maintain U.S. implementation materials aligned with global framework.
• Coordinate compliance, quality, safety, and inspection-readiness across EAP/OOS operations.
• Lead adoption of BOOST and related systems; manage user onboarding and data quality.
• Oversee U.S. vendor and service-provider management for EAP/OOS; define requirements and SLAs.
• Develop operational reporting; monitor metrics, risks, and continuous-improvement opportunities.

Skills

Program Leadership

Vendor Management

Cross-functional Collaboration

Governance Clarity

Operational & Resource Management

Risk & Quality Management

Data Fluency

Process Improvement

Education

Bachelor's degree required

Advanced degree preferred

Tools

BOOST

Veeva

Job description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The U.S. Early Access Program Manager provides centralized program management and operational enablement for Expanded Access Programs (EAPs) and individual Out-of-Scope (OOS) requests in the United States. The role translates the global Early Access Treatment framework into coordinated U.S. implementation; supports designated Local EAP Coordinators and Local TA OOS Leads; and manages integrated plans, timelines, dependencies, systems, service partners, documentation readiness, training, metrics, and escalations. Working across local & Corporate Medical Affairs, Regulatory Affairs, Patient Safety and Pharmacovigilance, Clinical Development & Operations, Quality Management, Legal & Compliance, supply functions, and external partners, the AD promotes timely, consistent, and inspection-ready execution. This role does not own the global EAT capability or replace the decision-making and execution accountabilities assigned to the Local EAP Coordinator, Local TA OOS Lead, U.S. Medical Director, or accountable Medical, Safety, Regulatory, Legal, Quality, Supply, and other designated functions.

Duties & Responsibilities

• Lead centralized U.S. program management and operational enablement for EAP/OOS activities. Establish integrated implementation plans, milestones, dependencies, governance touchpoints, and escalation pathways that translate the global EAT framework and approved U.S. requirements into coordinated execution across therapeutic areas and functions.
• Provide program-management support to designated Local EAP Coordinators for U.S. EAPs. Coordinate workplans, meetings, documentation readiness, vendor activities, system setup, regulatory and safety dependencies, product-supply interfaces, site readiness, budget tracking, and transition or closeout planning. The Local EAP Coordinator retains accountability for local EAP setup, conduct, and management under applicable procedures.
• Provide centralized process and platform support for U.S. OOS requests. Monitor workflow progression, pending actions, documentation completeness, system records, and operational handoffs; support Local TA OOS Leads and reviewers with approved guidance; and elevate delays or process issues. Local TA OOS Leads retain accountability for intake evaluation, request management, and TA-level coordination
• Coordinate the development and maintenance of U.S. implementation materials, including local working instructions, RACI, job aids, checklists, training content, and escalation guidance, in alignment with the global EAT framework and accountable U.S. functions. Assess global process changes and external requirements for U.S. operational impact and provide structured U.S. feedback to the GCO and global process owners.
• Coordinate compliance, quality, safety, and inspection-readiness support across EAP/OOS operations. Monitor required record creation, reconciliation, archival, and retrievability in BOOST, Veeva Clinical/OMP, and other designated systems. Partner with accountable functions on training, quality reviews, audits, deviations, CAPAs, and remediation, without assuming their professional or approval accountabilities.
• Lead U.S. adoption and effective use of BOOST and related operational systems. Perform or coordinate Local OOS Admin responsibilities, user onboarding, access and training support, data-quality monitoring, issue triage, release readiness, and U.S. enhancement input in partnership with global platform and system owners.
• Lead U.S. vendor and service-provider management for EAP/OOS operational support, including external expanded-access vendors and Human Pharma Services. Define U.S. service requirements and operating models; support vendor selection, due diligence, qualification, contracting, onboarding, and transition; establish RACI, service levels, deliverables, quality requirements, metrics, governance forums, issue management, and escalation routes; and coordinate performance reviews, corrective actions, budget oversight, renewals, and exit planning with Procurement and accountable functions.
• Develop U.S. operational reporting for EAP/OOS activities, including volume, status, cycle time, documentation completeness, training, system adoption, service performance, resource constraints, and emerging risks. Use approved metrics, stakeholder feedback, audit outcomes, and operational lessons to recommend U.S. improvements and support global continuous-improvement priorities

Requirements

• Bachelor's degree required, preferably in a related scientific, business, or clinical discipline; advanced degree (MA/MS/MBA) preferred
• 7+ years of relevant pharmaceutical industry and/or clinical research experience, including substantial program-management experience in Medical Affairs, Clinical Operations, Regulatory Affairs, Patient Safety, Quality, supplier management, or another regulated function.
• Demonstrated experience coordinating complex cross-functional programs from planning through implementation, monitoring, transition, and closeout. Direct experience with expanded access, compassionate use, named-patient programs, clinical research, investigational-product operations, or patient-access services strongly preferred.
• Working knowledge of FDA expanded access regulations and guidance, ICH-GCP principles, IRB and informed-consent expectations, pharmacovigilance interfaces, and applicable internal quality and compliance standards
• Program Leadership - ability to organize complex work, establish milestones and governance, manage dependencies, facilitate decisions, and elevate issues without assuming the accountabilities of therapeutic-area or specialist functions
• Vendor and Supplier Management - demonstrated ability to define service requirements, support sourcing and contracting, establish RACI and service levels, manage budgets and change requests, monitor quality and performance, lead governance reviews, and coordinate issue remediation and transition or exit plans
• Cross-functional Collaboration and Communication - ability to align global, U.S., therapeutic-area, functional, and external stakeholders and communicate requirements, risks, decisions, and status clearly
• Governance and Role Clarity - ability to apply approved decision frameworks, maintain clear ownership and handoffs, support accountable decision-makers, and prevent duplication or gaps
• Operational and Resource Management - ability to manage timelines, systems, service partners, workload, budgets, and competing priorities across multiple programs and requests
• Risk and Quality Management - ability to identify, assess, document, elevate, and monitor operational, supplier, compliance, safety, and inspection-readiness risks
• Data and Systems Fluency - ability to maintain data quality, interpret operational and vendor metrics, use dashboards and controlled systems, and translate performance trends into action
• Process Improvement and Change Leadership - ability to coordinate approved U.S. improvements, create practical guidance and training, support adoption, and assess effectiveness
• Patient and Customer Focus, sound judgment, attention to detail, discretion, resilience, and the ability to operate effectively under time-sensitive and ambiguous conditions.

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

Compensation

The base salary range for this position is $165,600 to $248,400. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law.

Benefits include medical, dental and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored programs.

For additional information regarding our benefits and Total Rewards offerings.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.