Associate Vice President – Early Development Clinical Research Physician, Neuroscience

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $268.5k - $466.4k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Serve as clinical lead to progress multiple early clinical assets into first-in-human studies and 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 patient-safety requirements • Review protocols, study reports, publications, data dissemination, product labels, grant submissions, and contracts • Engage with regulatory and governmental agencies and external clinical thought leaders • Ensure medical-team activities comply with local and international regulations, GCPs, company standards, Lilly policies, and medical research principles • Work with basic research scientists to plan preclinical studies and develop biomarker plans • Provide scientific and medical support to study teams and departments • Contribute to clinical development strategy and plans for clinical compounds • Support first-in-human dosing studies, Phase 2 and 3 planning, and biopharmaceutical submission planning • Collaborate with Global Patient Safety, PK/PD, ADME, statistics, modeling, and other functional teams • Design and oversee clinical pharmacology, biomarker qualification, mechanistic, and biopharmaceutical studies • Create and oversee study protocols and study-conduct documents • 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 study initiation and conduct requirements, including ethics review, informed consent, and regulatory approvals • Participate in study start-up meetings and train investigators and site personnel • Support clinical trial managers, monitors, investigators, and ethics boards during study conduct • Monitor patient safety and track and follow up on adverse events • Implement pharmacovigilance actions with global patient safety • Oversee third-party organizations supporting study execution • Address scientific questions from external healthcare professionals • Participate in clinical trial registry reporting, data analysis, publications, symposia, advisory boards, and final reports • Prepare clinical reports and regulatory documentation, including IND medical sections 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 medical strategies for commercialization, business development, payers, patients, and healthcare providers • Establish 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

🎯 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 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 hiring country • U.S.-trained physicians must have achieved board eligibility or certification • At least ten (10) years of pharmaceutical industry experience, or similar, relevant to clinical trial design and conduct of first-in-human and Phase 1 studies • Fluent in English, written and verbal • Expertise in early clinical development, including clinical pharmacology • Expertise in neuroscience drug development • Ability to engage in domestic and international travel approximately 10–15% • Knowledge of clinical trial design and conduct, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, and investigator/site management • Ability to comply with FDA, ICH, CPMP, GCPs, company standards, policies, and medical research principles • Strong communication, interpersonal, organizational, teamwork, and negotiation skills • Ability to influence others within teams and matrix environments • Pharmaceutical company experience preferable • Clinical and/or research experience in neuroscience, neurodegeneration, and/or pain research preferable • Broad clinical pharmacology experience preferable • Experience with genetic therapy modalities such as siRNA, ASO, and gene therapy preferable • Additional scientific training or degree (M.S., Ph.D.) preferable

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • 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 (ERGs) • Disability accommodation support during the application process