Director – Clinical Research Scientist

🔥 0 minutes ago

🏄 California – Remote

🏄 California – 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

• Provide scientific and clinical expertise across the drug development lifecycle and all clinical trial phases • Develop and contribute to global medical plans and clinical strategies • Develop and conduct clinical trials from trial design through regulatory submission and post-launch support • Partner with cross-functional teams on study design, medical plans, protocols, and development strategies • Align protocol design, trial conduct, reporting, timelines, data collection, grants, and governance reviews • 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 for clinical operations, investigators, and ethics boards • Plan clinical study data analysis and lead interpretation of study results • Support first-in-human, PK/PD-driven, and biomarker-driven clinical trial designs • Report clinical trial data in Clinical Trial Registry activities • Support data analysis, slide sets, final 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 collaborations with external experts, thought leaders, investigators, professional societies, and the medical community • Train investigators, site personnel, Lilly medical personnel, clinical study teams, and colleagues • Provide scientific/medical technical support for due diligence activities • Respond to unsolicited scientific inquiries from healthcare professionals • Support local labeling, labeling modifications, regulatory reports, NDAs, annual reports, PADERs, regulatory strategy, advisory committees, and registration efforts • Partner with brand and marketing teams on medical strategies, commercialization, Phase 3b/4 studies, payer programs, 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 • Relevant experience in clinical trials, drug development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs • Candidates with drug discovery or drug development experience only must provide 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 and internationally as needed • Fluency in English, written and verbal • Knowledge of Pain and Neurologic Disease diagnosis, pathophysiology, etiology, treatment, and management • Knowledge of clinical research methodology, biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards • Knowledge of applicable local laws, regulations, global policies, FDA, ICH, and GCP requirements • Required training and compliance certifications must be maintained

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare flexible spending accounts • Dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities • Employee resource groups (ERGs)