Develop and implement global epidemiology/RWE strategy, in collaboration with cross-functional and cross-regional partners, for one or more products or disease areas. Design, execute and report on epidemiology/RWE studies in support of BI´s products and indications. Provide strategic and methodological epidemiology/RWE advice to various in- and external stakeholders. Communicate effectively about how RWE can be used to support BI´s products and disease areas, and drive use of study results for evidence-based internal and external decision making.
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
- Collaborate cross-functionally to lead development of high quality global Real World Evidence strategies for assigned products and therapeutic areas.
- Design, execute, and oversee high-quality epidemiology/RWE studies, and ensure that results are effectively communicated to drive internal and external decision-making.
- Review and give high quality input to RWE/epidemiology studies designed by other functions/regions, as well as external publications, critical review assessments, regulatory document sections and other documents.
- Build collaborative relationships with other functions/regions within the company, and develop/maintain an external network within, and adjacent to, the field.
- Develop timely, high-quality epidemiology/RWE sections of regulatory documents for agencies worldwide, including submissions, RMPs, breakthrough or orphan designations, advisory committee briefing books, 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 and mentoring to cross-functional and cross-regional colleagues.
- Ensure fulfillment of regulatory requirements for GEpi-studies, e.g. registration, ethical board approval, disclosure. Complete epidemiology sections of regulatory documents and communications for agencies worldwide.
Requirements
- Doctoral degree (e.g. PhD, MD) and/or Master´s degree (e.g. MBA, MSc) in Epidemiology, HEOR, Medicine or related field from an accredited institution, with experience in pharma, CROs, or other closely related setting.
- Minimum of eight (8) years of relevant pharmacoepidemiology experience in Healthcare/Pharma/Biotech industry or Academia, or MD/PhD with a minimum of five (5) years of relevant pharmacoepidemiology experience in Healthcare/Pharma/Biotech industry.
- Trained Epidemiologist with strong methods training/analytical background and with experience designing, implementing, overseeing, and communicating about a variety of types of epidemiology/RWE studies.
- Strong, practical knowledge of epidemiology/RWE methods, data sources, and analytic tools.
- Experience in the pharmaceutical industry, ideally across multiple phases of development/commercialization, including interaction with cross-functional teams.
- Minimum of three (3) years of experience leading international multidisciplinary projects, with proven ability to run and communicate about own studies with little direction.
- Experience designing and conducting non-interventional/RWE studies, including protocol development and implementation, for multiple audiences (e.g. regulatory, payors, HCPs).
- Experience within the pharmaceutical industry or CRO, particularly within epidemiology, HEOR, or other related functions.
- 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).
- Knowledge of medical, regulatory, and payor systems in one or more regions of the world.
- Competent at developing and implementing strategies to address evidence needs for assigned products.
- Competent at working cross-functionally within a large, matrixed organization.
- Strong written and oral communication skills.
- Collaborative, proactive working style.
- Cross-cultural competency.
- Fluent English skills, additional European or Asian language a plus.
- Effective cross-functional, cross-cultural communication and negotiation skills.
- Ability to work under pressure, with a strong performance orientation, ability to prioritize across multiple projects, and effective collaboration in matrix structures.
Compensation
This position offers a base salary typically between $228,000 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.
#J-18808-Ljbffr