Director – Clinical Pharmacologist / Clinical Research Scientist

🔥 4 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

• Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies • Develop, conduct and report global clinical trials for new compounds • Implement global clinical trials and report adverse events according to corporate patient safety requirements • Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts and regulatory materials • Plan clinical strategies and clinical development programs for regulatory submissions • Support first-in-human dosing studies and biomarker plans • Collaborate with Global Patient Safety, PK/PD, ADME, Statistics and Tailored Therapeutics teams • Work with discovery research scientists on research strategies, candidate selection and pre-clinical development • Design and oversee clinical pharmacology studies, biomarker qualification studies and protocol development • Support study documents and collaborate with clinical research staff, statisticians, health outcomes scientists, consultants and investigators • Participate in investigator identification and selection, study start-up meetings and investigator/site training • Oversee ethical review, informed consent, regulatory approvals and study initiation requirements • Serve as a resource to clinical trial managers, monitors, investigators and ethical review boards • Monitor patient safety and implement pharmacovigilance actions • Oversee partnerships with Third Party Organizations for study execution • Address scientific questions from external health care professionals • Participate in clinical trial registry activities, publication strategy, data analysis and final reports • Present clinical trial results to corporate committees, regulatory agencies and external agencies • Prepare clinical reports and regulatory submissions, including medical sections of INDs and Investigator Brochures • Develop and retain a scientifically excellent workforce and foster inclusion, innovation and continual improvement • Support medical strategies for brand commercialization, business development and strategic brand planning • Maintain relationships with external experts and opinion leaders and support business-to-business and business-to-government activities

🎯 Requirements

• An advanced health/medical/scientific graduate degree (e.g., Pharmacology, physiology, microbiology) or a related graduate degree (e.g., PharmD, PhD, MSN) with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) • 3 years of pharmaceutical industry experience, or similar, relevant to clinical trial design and conduct of Phase 1 or Phase 2 studies • 3 years of clinical practice experience • Fluent in English, both written and verbal communications • Strong communication, interpersonal, organizational, teamwork and negotiation skills • Ability to influence others within teams and in a matrix environment • Ability to engage in domestic and international travel as appropriate to support the business of the team

🏖️ 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 • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities