Sr. Principal - Clinical Data Strategist at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Master’s degree with minimum 3 years of experience in data management (or Bachelor’s degree with 7 or more years of experience)
Legally authorized to be employed in the United States (no sponsorship anticipated)
Advanced degree (e.g., MSc, PhD) in a scientific or health care field (preferred)
Experience in clinical drug development with expertise in clinical data management, leading asset level clinical data strategies, defining clinical data flows, determining data modalities and/or defining requirements for data integration, mapping and normalization (preferred)
Demonstrated ability to effectively partner/influence to deliver results (preferred)
Demonstrated ability to understand and apply clinical data management skills, including data flow, data structures (preferred)

Responsibilities

Partner with internal and external teams to provide proactive strategic, scientific and technical input for clinical data planning and execution that enable efficient delivery of data
Drive project decisions related to clinical data execution options, including integrated functional sourcing, technology, automation, analytics and data collection modality
Ensure strong linkages exist between clinical design, execution, analytics, delivery and submission
Ensure data from different sources are consistent and easily consumable
Map collected data into predictable source/raw data
Collaborate with Clinical Data Associate and other Data and Analytics staff on data collection design
Understand inconsistencies in data and provide feedback to standards team
Support submission, inspection and regulatory response activities
Contribute to an agile organization that continuously meets the needs of a changing portfolio
Coach up staff who demonstrate expertise in drug development, therapeutic area science, project management and all aspects of clinical data sciences and solutions
Demonstrate and encourage judgment-based scientific decision making, and provide leadership in clinical data strategy, standardization, integration, analytics, automation and data submission
Provide scientific and technical leadership, coaching, and example to the community of Data & Analytics professionals
Foster inclusion, innovation and promote diversity

Skills

Clinical Data Strategy

Data Analytics

Clinical Research

Drug Development

Data Automation

Analytics

Data Integration

Data Collection

Therapeutic Area Strategy

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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