Director – Clinical Research Scientist

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $177k - $338.8k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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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

• Provide scientific and clinical expertise across the drug development lifecycle and all clinical trial phases • Develop and contribute to the global medical plan and clinical trials from trial design through regulatory submission and post-launch support • Collaborate with the Clinical Global Head in Pain and Neuroscience and cross-functional stakeholders on discovery and clinical development compounds • Understand pre-clinical and clinical data relevant to molecules in the Pain and Neuroscience therapeutic area • Contribute to global clinical strategy, clinical plans, launch label strategy, value proposition, and lifecycle planning • Partner with Discovery, Program Medicine, Clinical Pharmacology, Medical Affairs, and business-unit teams on study design, clinical strategies, medical plans, and protocols • Align protocol design, conduct, and reporting, and advise on tactical execution of development plans • Review and contribute to briefing documents, protocols, investigator brochures, study reports, and regulatory submissions • Review and approve local informed consent documents and risk profiles • Monitor patient safety and track and follow up on adverse events • Support investigator selection, site training, and study start-up activities • Serve as a scientific resource to clinical operations, investigators, and ethics boards • Plan clinical study data analyses and lead interpretation of results • Support first-in-human, PK/PD-driven, and biomarker-driven proof-of-concept trial design • Report clinical trial data in Clinical Trial Registry activities • Support data analysis and development of slide sets, study reports, abstracts, posters, and manuscripts • Support symposia, advisory boards, congresses, and healthcare professional meetings • Prepare or review scientific information for investigator questions and media requests • Establish relationships with external experts, thought leaders, investigators, professional societies, and the medical community • Train investigators, site personnel, and Lilly medical personnel • Provide scientific/medical technical support for due diligence • Respond to unsolicited scientific inquiries from healthcare professionals • Participate in local labeling, labeling modifications, regulatory reports, NDAs, annual reports, PADERs, regulatory strategy, and advisory committees • Support local registration efforts and resolution of regulatory issues • Partner with brand and marketing teams on medical strategies, commercialization, Phase 3b/4 studies, payer needs, promotional materials, and product value defense • Mentor and train clinical study teams and colleagues • Participate in DEI, coaching, and continuous improvement initiatives

🎯 Requirements

• Advanced degree (PharmD, PhD, DVM, MSN/NP, or related) plus 5+ years of clinical or pharmaceutical experience, OR BS/MS in a health, medical, or scientific field plus 7–10 years of relevant pharmaceutical experience in clinical trials, drug development, or related areas • For candidates with drug discovery or drug development experience only and no direct clinical trial experience: documented ownership of medical/scientific content development and endorsement from BU Medical Affairs/Development VP or senior leadership • Ability to balance scientific and business priorities • Strong communication, interpersonal, and negotiation skills • Ability to influence cross-functionally • Willingness to travel domestically/internationally as needed • Fluency in English, written and verbal • Knowledge of diagnosis, pathophysiology, etiology, treatment, and management of Pain and Neurologic Disease • Knowledge of clinical research methodology, biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards • Knowledge of and compliance with local laws, regulations, and global policies and procedures • Maintain required training/compliance certifications

🏖️ 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