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 data quality, protocol deviation management, and interpretation of emerging data
Contribute to the planning of data analyses and the interpretation of study results, and translate findings into recommendations that inform program decisions
Collaborate with clinical operations, CROs, and specialty vendors (e.g., central laboratory, imaging, and biomarker vendors) to ensure the scientific integrity, quality, and timely delivery of early phase studies
Scientific Data Dissemination & Exchange
Support data analysis and development of presentations, study reports, and publications (abstracts, posters, manuscripts)
Participate in clinical trial registration and results disclosure activities (e.g., ClinicalTrials.gov, EU CTR)
Support planning of symposia, advisory board meetings, and other engagements with healthcare professionals
Prepare or review scientific information in response to investigator questions
Establish and maintain collaborations with external experts, thought leaders, and the broader medical and scientific community
Develop and maintain relationships with relevant professional societies focused on neurodegeneration
Support training of medical personnel