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 several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Throughout the lifecycle of our assets, the U.S. Epidemiology and Real-World Evidence (EPI&RWE) 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 ensuring that an EPI&RWE 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 EPI&RWE 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 EPI&RWE. The job holder is responsible for overseeing study projects (NIS, IIS, RWE studies) around responsibility as applicable.

Duties & Responsibilities

Provides EPI&RWE oversight to US Early Asset TA Teams and the US Launch Team.

Leads content creation and provides training in the EPI&RWE area for the CDMA TA teams, and beyond as necessary:

Onboarding of new CDMA team members.

Training on methods and TA specific data.

Training on internal EPI&RWE processes.

Leads the following duties surrounding Asset Evidence Plan (AEP, Global) for assets assigned:

Provides strategic input on the AEP to ensure it reflects US EPI&RWE needs.

Cross-functional coordination for the development of the US EPI&RWE strategy during the entire life cycle of an asset.

Closely cooperates within the remit of the global EPI&RWE organization.

Focuses on market changes and possible external cooperation partners.

Closes networking within the entire regional EPI&RWE organization.

Responsible for the following duties surrounding US EPI&RWE Plan:

Ensures the development and execution of an asset-specific US EPI&RWE plan as part of Medical Affairs plan/ICP.

Establishes a timeline throughout the life cycle, with periodic adaptation and updating of the plans as needed.

Ensures early data/evidence generation.

Active integration of cross-functional perspectives.

Strategic and timely input for internal and external interface areas regarding EPI&RWE measures, access to data sources and their utilization.

Responsible for ensuring insights are integrated into decision-making and action:

Tracks and analyzes of asset-related activities in the US external environment.

Transfers the lessons learned and insights from external environmental into relevant internal teams and ensures appropriate actions.

Integrates external insights into BI measures.

Liaises with scientific institutions and methodological specialists.

Participates in discussions on methods of care research during symposia and congresses.

Anticipates and identifies potential issues and data gaps and ensure actions is taken accordingly.

Develops interdisciplinary study concepts in cooperation with the respective therapeutic areas and global EPI&RWE functions.

US Early Asset TA Team and US Launch Team:

Proactively participates in team meetings as appropriate to provide subject matter expertise on EPI&RWE topics.

Targets responses to relevant asset topics through appropriate innovative study concepts

Plans and commissions analysis and studies in the field of utility research, e.g., Analysis of disease frequencies, clinical treatment paths, treatment guidelines and patient preference together with colleagues from the cross-functional teams.

Close internal networking and cooperation with HEOR and BDS.

Transparently communicates lessons learned externally and internally.

Oversight for US CDMA EPI&RWE evidence gap analysis, studies, and projects:

This includes projects with a US lead function and/or US participation or global projects with the participation of US centers around responsibility.

Leads the design of non-interventional /observational studies incl. establishment of the monitoring plan considering the feasibility of medical practice and scientific accuracy, as well as a benefit-risk assessment during the study.

Regularly monitors the project status and initiation of any necessary corrections or measures.

Ensures that the relevant documentation of the relevant measure is available in the internal systems.

Ensures transmission to mandatory external documentation systems.

Requirements

Doctoral degree (e.g., PhD, MD) and/or Master’s degree (e.g., MBA, MSc) in Epidemiology, HEOR, Medicine or related field, with strong experience in pharma.

A minimum of eight (8) years of HEOR, epidemiology or RWE experience.

Strong conceptual, strategic, and analytical thinking.

Efficient, results-oriented work style.

Strong team and communication skills.

High performance and results orientation.

High level of initiative independently initiates pilot projects and takes the initiative.

Ability to interpret study data, study reports & publications, as well as the ability to assess their relevance to therapy, or Placing patients’ care in a medical context.

Solid internal and external overview of currently recognized methods and measures in the field of data generation and derived EPI&RWE, which exist for the successful development of an asset.

Ability to think networked (e.g., analysis of networks or decision processes).

Creative, curious and patient/customer and outcome oriented.

Independent working with high self-motivation, agile working methods and assumption of responsibility (AAI) with the ability to permanently re-prioritize.

Actively drive change in rapidly changing environments.

Openness to new and future-oriented ideas & new media.

Persuasion and presentation skills, negotiating skills.

Very good knowledge of English (oral and written communication).

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

This position offers a base salary typically between $220,000 and $350,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards) .

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.