Director – Clinical Research Scientist, Neurodegenerative Disease Early Phase Clinical Development

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $177k - $338.8k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Contribute to strategy, design, execution, analysis, and reporting of early-phase clinical trials for neurodegenerative diseases • Ensure activities comply with FDA, EMA, ICH, Good Clinical Practice, company standards, and applicable laws and regulations • Stay current with preclinical, translational, and clinical data relevant to the neurodegeneration portfolio • Collaborate on clinical strategy, development plans, protocol designs, dose and regimen selection, and biomarker and imaging strategies • Represent Lilly in external forums concerning neurodegenerative disease standards, assessment instruments, and clinical guidelines • Partner with the Clinical Research Physician and cross-functional teams on protocol development and trial execution • Author and review protocols, amendments, informed consent documents, Investigator’s Brochures, statistical analysis plans, and clinical study reports • Develop study operational documents, training materials, and study reference guides • Contribute to CRF design, site identification and selection, study start-up, investigator meetings, site training, and operational planning • Serve as a scientific resource to clinical operations, monitors, investigators, and ethics review boards • Support participant safety monitoring through review and follow-up of adverse events and safety data • Review clinical, safety, pharmacokinetic, and biomarker data to support data quality and program decisions • Collaborate with clinical operations, CROs, and specialty vendors to ensure scientific integrity, quality, and timely study delivery • Support analyses, presentations, study reports, publications, trial registration, results disclosure, symposia, and advisory boards • Establish relationships with external experts, thought leaders, professional societies, and the medical and scientific community • Support training of medical personnel and geographic/affiliate clinical research professionals • Contribute to regulatory documents and health authority interactions • Act as scientific consultant and protocol expert for study teams • Mentor and advise clinical research scientists and study team members; senior candidates lead cross-functional workstreams and represent the team in governance forums • Maintain professional development goals and required training and qualification records

🎯 Requirements

• Advanced degree in a health, medical, or scientific field (e.g., PhD, PharmD, DVM, or MSN with an advanced clinical specialty) 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 • Fluent in English, written and verbal • 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 neurodegenerative disorders • Familiarity with fluid and imaging biomarkers, clinical outcome assessments, diagnostic criteria, and neurodegeneration trial study designs • 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 such as Spotfire • Ability to interpret clinical trial efficacy, safety, and biomarker data • Experience contributing to regulatory documents and health authority interactions • Experience working with CROs and specialty vendors • Record of scientific contribution in neurodegeneration or neuroscience, such as peer-reviewed publications or congress presentations • Demonstrated ability to critically analyze, interpret, and communicate scientific and clinical data • 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% • Must be able to work Eastern Time business hours

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Remote-flexible work within the United States