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

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the strategy, design, execution, analysis, and reporting of early-phase clinical trials focused on neurodegenerative diseases.

• Ensure that all activities are in compliance with FDA, EMA, ICH, Good Clinical Practice, company standards, and relevant laws and regulations.

• Remain updated on preclinical, translational, and clinical data pertinent to the neurodegeneration portfolio.

• Collaborate on clinical strategies, development plans, protocol design, dose and regimen selection, as well as biomarker and imaging strategies.

• Represent Lilly in external discussions related to neurodegenerative disease standards, assessment tools, and clinical guidelines.

• Work alongside the Clinical Research Physician and cross-functional teams on protocol development and trial execution.

• Write and review protocols, amendments, informed consent documents, Investigator’s Brochures, statistical analysis plans, and clinical study reports.

• Create operational documents, training materials, and study reference guides for research studies.

• Contribute to the design of Case Report Forms (CRFs), site identification and selection, study initiation, investigator meetings, site training, and operational planning.

• Act as a scientific resource for clinical operations, monitors, investigators, and ethics review boards.

• Support participant safety monitoring by reviewing and following up on adverse events and safety data.

• Assess clinical, safety, pharmacokinetic, and biomarker data to ensure data quality and inform program decisions.

• Collaborate with clinical operations, CROs, and specialty vendors to uphold scientific integrity, quality, and timely delivery of studies.

• Assist in analyses, presentations, study reports, publications, trial registration, results disclosure, symposia, and advisory boards.

• Build relationships with external experts, thought leaders, professional societies, and the broader medical and scientific community.

• Aid in the training of medical personnel and clinical research professionals across geographic and affiliate locations.

• Contribute to regulatory documentation and engage with health authorities.

• Serve as a scientific consultant and protocol expert for study teams.

• Mentor and guide clinical research scientists and study team members; senior candidates will lead cross-functional workstreams and represent the team in governance forums.

• Maintain goals for professional development along with required training and qualification records.

⛳️ Requirements

• Advanced degree in a health, medical, or scientific discipline (e.g., PhD, PharmD, DVM, or MSN with an advanced clinical specialty) with over 5 years of experience in pharmaceutical or clinical research, including at least 3 years in clinical trial design, management, and execution; OR a bachelor’s or master’s degree in a health, medical, or scientific field with more than 10 years of relevant experience, including significant clinical trial design, management, and execution experience.

• Proficiency in English, both written and verbal.

• Direct experience leading operational activities in clinical trials such as protocol development, CRF design, investigator training, or study monitoring.

• Previous experience in the neurodegeneration or neuroscience therapeutic areas.

• Knowledge of the diagnosis, pathophysiology, etiology, treatment, and management of neurodegenerative disorders.

• Familiarity with fluid and imaging biomarkers, clinical outcome assessments, diagnostic criteria, and neurodegeneration trial designs.

• Experience in designing and executing early-phase clinical trials, including first-in-human, dose-escalation, and biomarker-driven proof-of-concept studies.

• Competence with electronic data capture systems, medical listings, and clinical data visualization tools such as Spotfire.

• Ability to analyze and interpret clinical trial efficacy, safety, and biomarker data.

• Experience in contributing to regulatory documents and engaging with health authorities.

• Experience collaborating with CROs and specialty vendors.

• A track record of scientific contributions in neurodegeneration or neuroscience, such as peer-reviewed publications or presentations at congresses.

• Proven ability to critically analyze, interpret, and communicate scientific and clinical data effectively.

• Strong skills in communication, interpersonal relations, teamwork, and organization.

• Ability to influence cross-functional partners and foster a positive, collaborative work environment.

• Willingness to travel domestically and internationally approximately 10–20% of the time.

• Must be available to work during Eastern Time business hours.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and opportunities for employee clubs and activities.

• Remote-flexible work options available within the United States.