Sr AD / Director, Epidemiology & RWE (Hybrid)

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 company's success. We realize that our strength and competitive advantage lie with our people.

 

As a SR Associate Director, you will collaborate with other epidemiologists and cross-functional partners to develop and implement global epidemiology/RWE strategies for one or more products or disease areas. Collaborate with colleagues to design, execute and report on epidemiology studies in support of assigned products and indications. Provide epidemiology/RWE methods advice to colleagues from other functions/regions within BI. Communicate effectively about global RWE strategy and study results with various internal stakeholders.

 

Throughout the lifecycle of our assets, the U.S. Real-World Evidence and Epidemiology (RWE&EPI) Therapeutic Area (TA) lead provides subject matter expertise to the U.S. Clinical Development and Medical Affairs (CDMA) TA team, contributing to the strategic direction of evidence generation plans that leverage real-world data to meet multi-stakeholder needs in the U.S. 

 

The Director RWE & EPI is responsible for leading the US integrated evidence generation process (IEGP) across assigned therapeutic area(s), including gap analysis driven by stakeholder insights and the development of tactics to address evidence and knowledge gaps across functions.

 

The Director RWE & EPI is responsible for ensuring that an RWE&EPI strategy is developed as part of the Medical Affairs plan/ICP, and that the plan is executed throughout the end-to-end life cycle of asset(s) within the respective TA. The objective of the RWE&EPI strategy is to drive medical engagements and generate evidence efficiently to enable access of treatments to patients at an early stage.

Through the incumbent’s expertise, they will influence strategic decisions at both a global and local level and assume a strategic scientific leadership position in US CDMA within the framework of RWE&EPI. The job holder is responsible for overseeing study projects (NIS, IIS, RWE studies) around responsibility as applicable.
 

Duties & Responsibilities

Sr AD Responsibilities

• Collaborate cross-functionally to develop high quality global Real World Evidence strategies for assigned products and therapeutic areas.
• Collaborate to design, execute, and oversee high- quality epidemiology/RWE studies, and ensure that results are effectively communicated to key internal and external audiences.
• Review and give technical input on RWE/epidemiology studies, as well as external publications, critical review assessments, and other documents.
• Build collaborative relationships with other functions/ regions within the company, and begin to develop/ maintain an external network within the field.
• Collaborate to develop timely, high-quality epidemiology/RWE sections of regulatory documents for agencies worldwide, including submissions, RMPs, breakthrough or orphan designations, etc.
• Participate in development of new processes, SOPs, trainings, and working documents relevant for the implementation of Epidemiology/RWE at BI.
• Provide epidemiology/RWE methods consultation to cross- functional and cross-regional colleagues.
• Collaborate with team members to ensure fulfillment of regulatory requirements for GEpi-studies, e.g. registration, ethical board approval, and disclosure. Draft epidemiology sections of regulatory documents and communications for agencies worldwide.

 

Director Responsibilites

RWE&EPI Oversight:

• Provides RWE&EPI oversight to US Early Asset TA Teams and the US Launch Team.
• Leads content creation and training for CDMA TA teams, including onboarding, methods, TA-specific data, and internal processes.

Asset Evidence Plan (AEP):

• Provides strategic input on AEP to reflect US RWE&EPI needs.
• Coordinates cross-functional development of US RWE&EPI strategy.
• Cooperates with global RWE&EPI organization.
• Focuses on market changes and external cooperation partners.
• Networks within the regional RWE&EPI organization.

US RWE&EPI Plan:

• Develops and executes asset-specific US RWE&EPI plan as part of Medical Affairs plan/ICP.
• Establishes and updates timelines throughout the asset life cycle.
• Ensures early data/evidence generation and cross-functional integration.
• Provides strategic input for RWE&EPI m