Post Doctoral Fellowship: Global Patient Safety

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 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.

When it comes to research and development, our goal is to discover and deliver innovative medicines that make life better for people around the world. It’s challenging, expensive and often filled with failure. But even when we fail, we advance medical science and understanding by learning more about diseases, biology and chemistry – ultimately bringing new solutions one step closer to reality.

Over the course of our history, we have shed light on some of the toughest health care problems known to man – diabetes, heart disease, infectious diseases, neuroscience disorders, cancer and more. We could not pursue this without our research and development team.

Postdoctoral scientists help us continue this pursuit. During your experience you will get:

• Top industry research experience
• Mentoring by some of Lilly’s top scientists
• Laboratory and classroom training and education to further your development (as needed)
• Collaboration and networking across dozens of postdoctoral scientists and other researchers

We are seeking an ambitious post-doctoral scientist with strong research and communication skills to contribute to the advancement of machine learning (ML)–based approaches for identifying risk factors associated with key safety topics.

Purpose of the Job

In this role, you will utilize innovative ML and rare event modeling techniques to investigate risk factors and protective factors associated with serious or severe drug adverse events that have not been extensively studied to date. The initial focus will be on neuroscience, with the methodology subsequently extended to other critical events and therapeutic areas. This work will enhance our understanding of the drivers behind these safety concerns and strengthen our ability to evaluate the benefit-risk profile of investigational and marketed therapies.

This work will support the activities of the Global Patient Safety (GPS) Medical organization which characterizes and communicates the safety profile of Lilly medicines, assesses benefit-risk, and plans and measures risk minimization measures across Lilly’s portfolio. GPS Medical partners with the business units, Global Scientific Communication, Global Regulatory Affairs, Statistics, and other functions to develop clinical plans, influence study protocol design, conduct medical surveillance, and more. Analysis of safety data is key to achieving these goals; therefore, the Advanced Intelligence group is another key partner liaising with GPS Medical. Advanced Intelligence leverages advanced statistical capabilities (including ML and other types of artificial intelligence) to enhance safety data analysis.

The main expected outcome of this project is the generation of scientific data revealing new clinical insights into risk factors driving adverse events of special interest for key Lilly products. Further, the methodology will be adapted to other compounds both in development and in the market. These findings offer strong potential for publication in high-impact peer-reviewed journals, advancing scientific understanding of disease processes and benefiting stakeholders across industry, government, and academia.

The candidate will develop key skills in pharmacovigilance and safety science (particularly with respect to novel methodologies), have extensive professional networking opportunities via collaborations with colleagues in Medical, Statistics, Toxicology, and Advanced Intelligence, gain experience in the pharmaceutical industry at multiple lifecycle stages, and leverage opportunities to share findings with the external scientific community.

Key Objectives

ML-Based Risk Factor Modeling

Develop and validate ML models to predict safety outcomes in the medical domain including adverse events, complications, or treatment-related risks by identifying risk factors such as patient histories, concomitant medications, imaging, and other clinical parameters. Employ advanced techniques including ensemble methods, resampling strategies, cost-sensitive learning, and anomaly detection to address rare event prediction and improve model robustness.

External Scientific Communication

Present findings at conferences and publish in high-impact peer-reviewed journals.

Safety Surveillance Improvement

Understand current medical surveillance and signal management processes. Leverage enhanced understanding of adverse events of special interest for Lilly medicines to explore improvements to routine medical surveillance. Make recommendations on integration and standardization of new methodologies into existing safety data analysis platforms and processes to improve consistency and accuracy of data review across Lilly products.

Internal and External Collaboration

Communicate effectively with relevant internal business partners. Collaborate with early phase medicine and business unit teams and Regulatory Scientists as part of issue management and in preparation of responses to requests made by regulatory authorities. Share findings and collaborate on methodologies with Advanced Intelligence. Collaborate with external partners and participate in key external initiatives to benefit the organization.

Global Patient Safety Support

Demonstrate knowledge of relevant global regulatory requirements and practices. Act as subject matter expert in the development and maintenance of safety quality system documents and training tools. Provide medical support to GPS safety teams. Demonstrate understanding of the roles and responsibility of the EU QPPV. Support audit readiness. Identify areas of key need across clinical development and champion creative solutions to address those needs.

Basic Qualifications

• An advanced analytical, statistical, bioinformatics, or medical-related graduate degree (Ph.D., PharmD)

Additional skills

• Competency in independent analysis of data and interpretation of results from clinical studies.
• Excellent computer skills and interdisciplinary experience in statistical modeling and computer sciences, including ML.
• Proficiency in programming languages including Python and R with experience using key ML libraries (e.g., scikit-learn, XGBoost, TensorFlow).
• Self-directed and highly motivated nature with a desire to learn new techniques while continually pursuing research and publication goals.
• Excellent communication (oral and written), presentation experience, and strong publication record.
• Proficiency in data analysis and reporting.
• Experience in drug safety is not required.

Other Information

• This position is located in Indianapolis, Indiana (office-based), remote is not considered.

• This position is not permanent. It is for a fixed duration of two years with the potential to extend to three years. You will have opportunities to apply for full-time positions after your duration is complete.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$58,000 - $123,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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