At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We re looking for people who are determined to make life better for people around the world.
The Real World Evidence (RWE) Hub within the Medicines Development Unit (MDU) is responsible for working with business units and affiliates to improve individual patient outcomes through credible and timely real world evidence, thereby creating value for customers. The RWE Hub is a cross-functional hub hosted by GPORWE (in collaboration with IT, Biometrics, and Global Patient Safety) to enable enterprise-wide co-ordination of the data strategy, infrastructure & partnerships. The RWE Hub leads development of innovative RWE related capabilities and partners with RWE organizations throughout the enterprise (RWE Community) to differentiate Lilly in delivering RWE sources of value. The Real World Data Senior Associate is responsible for developing and implementing RWD strategies and solutions to address scientific questions raised throughout the drug development lifecycle. You will leverages interdisciplinary knowledge of the healthcare system, database structures and management, and problem solving within processes and systems to extract knowledge and insights from multiple data types. The position requires strong external focus and continuous learning to maintain expertise in RWD types, RWD access methods, personal health information, novel data linkage methods, and understanding of industry requirements and innovations. In this role, you will provides technical leadership and scientific expertise to identify and access key RWD sources in support of a particular business unit, therapeutic area, and/or geography. Additionally, you will partners with research teams to determine appropriate RWD sources, RWD access methods, how variables should be developed, and RWD format to enable efficient delivery of RWE solutions. The span of the role covers the entire drug development lifecycle and encompasses RWD sources including clinical, social/ behavioral, biologic, and genomic data.
Real World Data Strategy
Develop, communicate, and drive implementation of a global RWD strategy and associated RWD plan addressing the full lifecycle of the assigned portfolio of the BU, therapeutic area, and/or geography.
Implement and be accountable for a lifecycle management strategy for assigned assets in the Lilly RWD & Insights Platform This strategy ensures that the structure, content and meaning, access, acquisition, storage, retrieval, interchange, data use requirements, and representation of the data are documented in Pangaea, well understood, and person-independent, and that the RWE hub is able to respond to questions from enterprise-wide business partners about the RWD at any time.
Develop and ensure that deep knowledge of internal, external and regulatory requirements (e.g. OMOP, Sentinel, HL-7, FHIR, MHRA, FDA, ICH, GCP, CDISC, PhRMA, etc.) as well as trends relevant to RWD are understood, well communicated, and applied to data deliverables and global RWD strategy.
Influence external organizations to further Lilly interests in the industry.
Access to and Maintenance of RWD
Conduct in-depth evaluation of RWD sources proposed in the RWD strategy to identify potential internal multi-use assets as well as assets accessible only via third parties. Assets will be evaluated to determine the value of investment in the RWD asset and optimal access method (e.g. acquisition, cloud service, RWE external partnership, or third party).
Establish and communicate the appropriate data structure and format of acquired RWD sources to allow accurate use across the intended user base.
Guide processes to establish RWD access methods (e.g. internal, cloud, third party) for each data source in the RWD Plan in partnership with procurement, RWE hub, IT, project management, and business partners.
Develop, maintain, and implement a data access and management plan for assigned assets in the Lilly RWD & Insights Platform. This may include responsibilities performed by third parties managing data on Lilly s behalf.
Maintain current RWD information in the RWE business process and knowledge management solution, Pangaea.
Develop standards and best practices for medical coding and algorithms to define variables for RWE specific to the RWD source, BU, or therapeutic area.
Proactively drive the use of data processes and tools to expedite use and impact of the RWD Plan, including input to the design and application of data interrogation tools (e.g. visualization in Tableau, dashboards/reports, cohort generator).
Bring greater value to the portfolio by leveraging knowledge of the use and flow of RWD in the healthcare setting and of the BU or therapeutic area to anticipate issues and identify opportunities to which RWD solutions can be applied, including identifying new applications of RWD, approaches to non-traditional sources of RWD (e.g. connected care, mHealth, linked data).
Extract value from RWD sources and RWD providers through strategic development of relationships, including mutual benefit partnerships, volume discounts, single use, or long-term investments in collaboration with RWE PM consultant.
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort to maximize the return of the investment (i.e. technology purchases, data strategies) of the assets/domains managed.
Understand the confidential nature of RWD, personal health information, and company information and take necessary steps to ensure its protection. This includes understanding various aspects of privacy as it relates to RWD and Protect Lilly.
Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
Accept obligation of Lilly to comply with requirements of RWD asset and solution owners, including adherence to contracts outlining access, maintenance, use, and storage of data.
Bachelor's Degree in a health-related field.
Bachelor's Degree with 3+ years of experience in a health related field.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Demonstrated understanding of the flow of data and information within the healthcare environment.
Demonstrated ability to understand and apply data flow, data quality, data interchange, data interrogation, and data representation principles.
Demonstrated knowledge specific to a business unit, geography or therapeutic area.
Familiarity with RWD tools and technologies.
Strong agility in using computer software, including data visualization tools (e.g. Tableau, Spotfire) and Microsoft Office
Demonstrated ability to lead and influence (without authority) to achieve team deliverables.
Leadership, independent and team-based decision making, negotiation, and conflict management skills at a consultant level.
Excellent oral and written communication skills: able to communicate clearly and succinctly with team members and leadership.
Strong problem-solving skills: able to recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team.
Higher degree or 8-10 years of work experience in the pharmaceutical and/or drug development.
Demonstrated knowledge of drug development across the product lifecycle, commercial awareness, business acumen, and customer focus.
Deep therapeutic and clinical knowledge in the specific BU or therapeutic area supporting.
Vendor or alliance management experience
Domestic and International travel will be required
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.