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

Overview

Clinical Research Scientist on Lilly's Neurodegenerative Disease Early Phase Clinical Development team, partnering with the Clinical Research Physician and cross-functional teams on early phase clinical trials for Alzheimer's disease, Parkinson's disease, ALS and other neurodegenerative disorders.

What you'll do

• Stay current with preclinical, translational and clinical data relevant to the neurodegeneration portfolio and contribute to global alignment of clinical strategy and development plans.
• Collaborate with Exploratory Medicine & Pharmacology, Discovery and Clinical Design, Delivery, and Analytics on protocol designs, clinical development plans and clinical strategies.
• Contribute to early clinical development plans, including first-in-human, dose-escalation and proof-of-concept study designs, dose and regimen selection, and biomarker and imaging strategies supporting go/no-go decisions.
• Represent Lilly in external forums where standards, assessment instruments and clinical guidelines for neurodegenerative diseases are discussed.
• Partner with the Clinical Research Physician on scientific, technical and operational aspects of protocol development and trial execution.
• Author, review and collaborate on the scientific content of 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 and participate in site identification and selection.
• Work with cross-functional stakeholders on the design, conduct and reporting of early phase trials, including sample size, patient commitment, timelines and governance reviews.
• Review and, with the Clinical Research Physician, 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 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, monitors, investigators and ethics review boards during study conduct.
• Support the Clinical Research Physician in monitoring participant safety, including review, tracking and follow-up of adverse events and safety data.
• Perform ongoing review of clinical, safety, pharmacokinetic and biomarker data to support data quality, protocol deviation management and interpretation of emerging data.
• Contribute to planning of data analyses and interpretation of study results, translating findings into recommendations that inform program decisions.
• Collaborate with clinical operations, CROs and specialty vendors to ensure scientific integrity, quality and timely delivery of early phase studies.
• Support data analysis and development of presentations, study reports and publications, and participate in clinical trial registration and results disclosure.
• Support planning of symposia, advisory board meetings and other engagements with healthcare professionals, and prepare or review scientific information in response to investigator questions.
• Establish and maintain collaborations with external experts, thought leaders and professional societies focused on neurodegeneration.
• Support training of medical personnel, including geographic/affiliate clinical research professionals and medical liaisons.
• 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 such as pre-IND and end-of-Phase 2 meetings and scientific advice, with Regulatory Affairs and the Clinical Research Physician.
• Critically read and evaluate medical literature, stay informed on the competitive landscape, and act as scientific consultant and protocol expert for study team members.
• Mentor and advise other clinical research scientists and study team members; senior candidates will lead cross-functional workstreams and represent the team in governance forums and external interactions.
• Model Lilly leadership behaviors, set and meet professional development goals, contribute to recruitment, and maintain required training and qualification records.

What you'll need

• 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).
• Fluent in English (written and verbal).

Nice to have

• Direct experience leading clinical trial operational activities such as protocol development, CRF design, investigator training or study monitoring.
• 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 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 ability to interpret 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.
• Willingness to travel domestically and internationally (approximately 10–20%).

Details

• Location: remote-flexible within the United States.
• Candidates must be able to work Eastern Time (ET) business hours to collaborate with the core team.
• Reports to the Associate Vice President, Neurodegenerative Disease Early Phase Clinical Development.
• Employment type: full-time.
• Anticipated wage $177,000 - $338,800, depending on education, experience, skills and geographic location; eligible for company bonus.