Sr AD / Director, Epidemiology & RWE (19465)

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. 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.

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 measures and data source utilization.

Decision-Making and Action:

• Tracks and analyzes asset-related activities in the US external environment.
• Transfers lessons learned to internal teams and ensures appropriate actions.
• Integrates external insights into BI measures.
• Liaises with scientific institutions and participates in symposia and congresses.
• Identifies potential issues and data gaps, ensuring actions are taken.
• Develops interdisciplinary study concepts with therapeutic areas and global RWE&EPI functions.

Team Participation:

• Participates in team meetings to provide RWE&EPI expertise.
• Targets responses to asset topics through innovative study concepts.
• Plans and commissions utility research studies with cross-functional teams.
• Networks and cooperates with HEOR and BDS.
• Communicates lessons learned externally and internally.

Evidence Gap Analysis and Projects:

• Leads US and global projects with US participation.
• Designs non-interventional/observational studies, ensuring feasibility and scientific accuracy.
• Monitors project status and initiates necessary corrections.
• Ensures relevant documentation is available in internal and external systems.

Requirements

Sr AD level Education Requirements: 

• Master´s degree (e.g. MBA, MSc) in Epidemiology, HEOR, Medicine or related field from an accredited institution, with a minimum of six (6) years of relevant pharmaceoepidemiology experience; Or
• Doctoral degree (e.g. PhD, MD) in Epidemiology, HEOR, Medicine or related field from an accredited institution, with a minimum of three (3) years of relevant pharmaceoepidemiology experience.
• Trained epidemiologist with strong methods training, and analytical background, overview-level knowledge of one or more global healthcare systems.
• Experience designing, implementing, and overseeing epidemiology/RWE studies using one or more different designs.
• Experience developing and conducting epidemiology/RWE studies.
• Experience with secondary data analysis, including studies using healthcare claims and/or electronic Medical Record databases.
• Analysis experience with one or more analytic tools (e.g. SAS, R, analytic platforms).
• Experience working in epidemiology or a related field within pharma, CRO´s, government, or academia
• Experience participating on cross-functional teams Collaborative, proactive working style.
• Experience within the pharmaceutical industry or CRO, particularly within epidemiology, HEOR, or other related functions a plus.
• Ability to collaborate to develop RWE strategy documents to address evidence needs for assigned products.
• Strong, practical knowledge of epidemiology/RWE methods, data sources, and analytic tools.
• Fluent English skills, additional European or Asian language a plus.
• Ability to work under pressure, with a strong performance orientation, ability prioritize across multiple projects, and effective collaboration in matrix structures.
• Ability to prioritize and work on multiple projects at a time.
• Strong written and oral communication skills.
• Cross cultural competency.

Director level Education 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).
 

Compensation

This position offers a base salary typically between $170,000 and $269,000 for SR AD level and $220,000 and $350,000 for the Director level. 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.