Director – Clinical Pharmacologist, Clinical Research Physician

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $201k - $393.8k / 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, product labels, grant submissions, contracts, and regulatory materials • Conduct outreach to external clinical customers and thought leaders • Ensure medical-team activities comply with local and international regulations, FDA, ICH, CPMP, GCPs, company standards, and Lilly policies • Work with basic research scientists to plan pre-clinical studies and develop biomarker plans • Serve as a scientific and medical resource for study teams and departments • Contribute to clinical development strategies and plans for clinical compounds • Support first-in-human dosing preparations, Phase 2 and 3 planning, and biopharmaceutical submission planning • Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics, and quantitative-science teams • Work with discovery research scientists on research strategies, candidate selection, and pre-clinical development • Collaborate with Brand Team and Business Unit colleagues on market differentiation and regulatory support • Design and oversee clinical pharmacology, mechanistic, development, and biomarker qualification studies • Develop protocols and study-conduct documents in accordance with GCP and local requirements • Collaborate with clinical research staff, statisticians, health outcomes scientists, consultants, and investigators • Participate in investigator identification and selection • Review risk profiles and informed-consent documents • Oversee ethical review, informed consent, regulatory approval/notification, study start-up, training, and site activities • Advise clinical trial managers, monitors, investigators, and ethical review boards during studies • Monitor patient safety, track and follow up adverse events, and implement pharmacovigilance actions • Provide oversight and partnership to third-party organizations for study execution • Address scientific questions from external healthcare professionals • Participate in clinical trial registry reporting, publication strategy, scientific communications, data analysis, final reports, and publications • Present clinical trial results to corporate committees, regulatory agencies, and external agencies • Prepare clinical reports and regulatory reports, including medical sections of INDs and Investigator Brochures • Support FDA advisory committee hearings, label discussions, and regulatory issue resolution • Develop and retain a scientifically excellent workforce and foster inclusion, innovation, and continual improvement • Support commercialization and medical strategies with business units, New Product Planning, and business development • Maintain relationships with external experts and opinion leaders • Support business-to-business and business-to-government activities as a medical expert • Contribute to ongoing strategic brand planning and understand market archetypes

🎯 Requirements

• Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) • Non-U.S. trained physicians must have completed education and training at a medical school meeting Liaison Committee on Medical Education (LCME) requirements • Must be board eligible or certified in an appropriate specialty/subspecialty, or have completed comparable post-medical-school clinical training relevant to the country of hiring • U.S.-trained physicians must have achieved board eligibility or certification • At least two years of pharmaceutical industry experience, or similar, relevant to Phase 1 and Phase 2 clinical trial design and conduct • Experience with clinical programs, trials and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, and investigator/site management • Fluent in English, written and verbal • Ability to engage in domestic and international travel, approximately 10–15% • Demonstrated strong communication, interpersonal, organizational, teamwork, and negotiation skills • Demonstrated ability to influence others within teams and a matrix environment • Additional scientific training or degree (M.S., Ph.D.) preferable • Pharmaceutical company experience preferable • Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable • Experience in Clinical Pharmacology preferable

🏖️ Benefits

• Company bonus depending 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 • Employee resource groups open to all employees • Disability accommodation support during the application process