Director - Clinical Research Scientist - Neurodegenerative Disease Early Phase Clinical Development
Remote · Not stated
Hiring locations: US: USA Remote
Open posting at Eli LillyCheck the posting for country and time zone requirements before applying.
Employer’s description
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, including geographic/affiliate clinical research professionals and medical liaisons Regulatory Support • Contribute to the medical and scientific content of regulatory documents, including INDs/CTAs, briefing documents, Development Safety Update Reports, and responses to health authority questions • Support preparation for and participation in health authority interactions (e.g., pre-IND and end-of-Phase 2 meetings, scientific advice) in collaboration with Regulatory Affairs and the CRP Scientific & Technical Expertise • Critically read and evaluate the relevant medical literature; stay informed on competitive landscape and scientific developments in neurodegeneration • Act as scientific consultant and protocol expert for clinical study team members • Be aware of current trends and projections for diagnostic and clinical practice in Alzheimer's disease, Parkinson’s disease, ALS, and other neurodegenerative disorders • Attend and contribute to scientific symposia and relevant training opportunities • Maintain working knowledge of clinical research methodology relevant to neurodegeneration, including fluid and imaging biomarkers, clinical outcome assessments, digital and remote assessment tools, study designs, safety evaluation, and regulatory standards Leadership & Professional Development • Mentor and advise other clinical research scientists and study team members in the neurodegeneration therapeutic area; senior candidates will be expected to lead cross-functional workstreams and represent the team in governance forums and external interactions • Model Lilly leadership behaviors, actively set and meet individual professional development goals, and contribute to the development of others and to recruitment efforts • Maintain required training and qualification records (learning plan/curriculum) current at all times Qualifications Basic Qualifications • Advanced degree in a health, medical, or scientific field (e.g., PhD, PharmD, DVM, or MSN with an advanced clinical specialty such as Clinical Nurse Specialist or Nurse Practitioner) with 5+ years of pharmaceutical or clinical research experience, including at least 3 years of direct clinical trial design, management, and execution experience OR Bachelor’s or Master’s degree in a health, medical, or scientific field with 10+ years of pharmaceutical or clinical research experience, including substantial clinical trial design, management, and execution experience (e.g., protocol development, study start-up, site management, clinical data review, or trial conduct) Additional Skills/Preferences • Direct experience leading clinical trial operational activities such as protocol development, CRF design, investigator training, or study monitoring • Fluent in English (written and verbal) • Prior experience in the neurodegeneration or neuroscience therapeutic area • Knowledge of diagnosis, pathophysiology, etiology, treatment, and management of Alzheimer's disease, Parkinson's disease, ALS or other neurodegenerative disorders • Familiarity with biomarkers (e.g., plasma and CSF biomarkers, amyloid and tau PET, MRI), clinical outcome assessments (e.g., CDR-SB, ADAS-Cog, iADRS, MDS-UPDRS, ALSFRS-R), diagnostic criteria, and study designs used in neurodegeneration trials • Experience with early phase clinical trial design and execution, including first-in-human, dose-escalation, and biomarker-driven proof-of-concept studies • Proficiency with electronic data capture systems, medical listings, and clinical data visualization tools (e.g., Spotfire), and demonstrated ability to interpret clinical trial efficacy, safety, and biomarker data • Experience contributing to regulatory documents (e.g., IND/CTA, Investigator’s Brochure, briefing documents) and to health authority interactions • Experience working with CROs and specialty vendors (e.g., central laboratory, imaging, or biomarker vendors) • Record of scientific contribution in neurodegeneration or neuroscience (e.g., peer-reviewed publications or congress presentations) • Demonstrated ability to critically analyze, interpret, and communicate scientific and clinical data to diverse audiences • Strong communication, interpersonal, teamwork, and organizational skills • Ability to influence cross-functional partners and create a positive, collaborative working environment • Willingness to travel domestically and internationally (approximately 10–20%) Additional Information Reports to: Associate Vice President, Neurodegenerative Disease Early Phase Clinical Development. Location: This role is remote-flexible within the United States. Candidates must be able to work Eastern Time (ET) business hours to collaborate with the core team. 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 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. #WeAreLilly