Director - Clinical Research Scientist - Neurodegenerative Disease Early Phase Clinical Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. About Lilly At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. About the Team Lilly’s Neurodegenerative Disease Early Phase Clinical Development team plays a pivotal role in developing new medicines for brain disorders such as Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, and amyotrophic lateral sclerosis (ALS). The team leads and co-leads drug programs and therapeutic strategies from early preclinical stages through Phase 1 and Phase 2 clinical studies, across multiple modalities including antibodies, small molecules, and genetic medicines, in close partnership with Lilly’s discovery, translational, biomarker, and imaging groups. About the Role We are seeking a Clinical Research Scientist (CRS) to join our Neurodegenerative Disease Early Phase Clinical Development team. In partnership with the Clinical Research Physician (CRP) and cross-functional partners, you will contribute to the strategy, design, execution, analysis, and reporting of early phase (first-in-human through proof-of-concept) clinical trials for Alzheimer's disease, Parkinson’s disease, ALS, and other neurodegenerative disorders, and play a key role in advancing our pipeline from early clinical development into later stages of development. The Clinical Research Scientist must ensure that all activities comply with current local and international regulations, laws, and guidance (e.g., FDA, EMA, ICH), Good Clinical Practice (GCP), company standards, Lilly policies and procedures, and the Principles of Medical Research. The core job responsibilities include those listed below as well as all other duties as assigned. Responsibilities Clinical Planning & Strategy Stay current with preclinical, translational, and clinical data relevant to molecules in the neurodegeneration portfolio Contribute to global alignment of clinical strategy and development plans consistent with therapeutic area priorities Collaborate with cross-functional partners, including Exploratory Medicine & Pharmacology (EMP), Discovery, and Clinical Design, Delivery, and Analytics (CDDA), in the development of study protocol designs, clinical development plans, and clinical strategies consistent with the known biological characteristics of the molecules Contribute to early clinical development plans, including first-in-human, dose-escalation, and proof-of-concept study designs; dose and regimen selection; and integrated biomarker and imaging strategies that support go/no-go decisions Represent Lilly in external forums where standards, assessment instruments, and clinical guidelines for neurodegenerative diseases are discussed Clinical Trial Execution & Support Partner with the Clinical Research Physician (CRP)/medical monitor on the scientific, technical, and operational aspects of protocol development and trial execution Author, review, and collaborate on the scientific content of clinical documents, including protocols and amendments, informed consent documents, Investigator’s Brochures, statistical analysis plans, and clinical study reports Develop and maintain study operational documents such as the manual of operations, training materials, and study reference guides Contribute to the design and review of case report forms (CRFs) to ensure accurate and complete data capture Participate in site identification and selection activities in conjunction with clinical operations Work with cross-functional stakeholders on the design, conduct, and reporting of early phase clinical trials (sample size, patient commitment, timelines, governance review interactions) Review and, in collaboration with the CRP, approve risk profiles to ensure appropriate communication of risk to study participants Ensure operational teams document completion of administrative requirements for study initiation and conduct (IRB/ethics review, informed consent, regulatory notification) consistent with GCP and local requirements Lead or participate in study start-up meetings, investigator meetings, and site training activities Serve as a scientific resource to clinical operations, clinical research monitors, investigators, and ethics review boards to address questions or clarify issues during study conduct Support the CRP in monitoring participant safety during studies, including review, tracking, and follow-up of adverse events and safety data, in alignment with Global Patient Safety policies and procedures Perform ongoing review of clinical, safety, pharmacokinetic, and biomarker data (e.g., medical listings and data visualizations) to support