Associate Vice President – Early Development Clinical Research Physician, Neuroscience

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the clinical lead to advance multiple early clinical assets into first-in-human studies and facilitate further development through clinical pharmacology and mechanistic studies.

• Design, execute, and report global clinical trials for new compounds.

• Manage global clinical trials and report adverse events in compliance with patient-safety requirements.

• Evaluate protocols, study reports, publications, data dissemination, product labels, grant submissions, and contracts.

• Collaborate with regulatory and governmental agencies as well as external clinical thought leaders.

• Ensure that medical-team activities adhere to local and international regulations, GCPs, company standards, Lilly policies, and principles of medical research.

• Partner with basic research scientists to plan preclinical studies and develop biomarker strategies.

• Provide scientific and medical support to study teams and departments.

• Contribute to the clinical development strategy and plans for clinical compounds.

• Aid in 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 supervise clinical pharmacology, biomarker qualification, mechanistic, and biopharmaceutical studies.

• Develop and manage study protocols and study-conduct documents.

• Work closely with clinical research staff, statisticians, health outcomes scientists, consultants, and investigators.

• Engage in investigator identification and selection.

• Review risk profiles and informed-consent documents.

• Supervise study initiation and conduct requirements, including ethics review, informed consent, and regulatory approvals.

• Participate in study start-up meetings and provide training for investigators and site personnel.

• Assist clinical trial managers, monitors, investigators, and ethics boards throughout the study conduct.

• Monitor patient safety and track and follow up on adverse events.

• Implement pharmacovigilance measures alongside global patient safety.

• Oversee third-party organizations involved in study execution.

• Address scientific inquiries from external healthcare professionals.

• Engage 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 resolution of regulatory issues.

• Cultivate a scientifically excellent workforce while promoting inclusion, innovation, and continuous improvement.

• Assist with medical strategies for commercialization, business development, payers, patients, and healthcare providers.

• Build relationships with external experts and opinion leaders.

• Support business-to-business and business-to-government initiatives 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 their education and training at a medical school that meets 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.

• A minimum of ten (10) years of experience in the pharmaceutical industry or a similar field, particularly in clinical trial design and the conduct of first-in-human and Phase 1 studies.

• Proficiency in English, both written and verbal.

• Specialized knowledge in early clinical development, particularly clinical pharmacology.

• Expertise in neuroscience drug development.

• Willingness to travel domestically and internationally approximately 10–15% of the time.

• Familiarity with clinical trial design and execution, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, and investigator/site management.

• Ability to adhere to FDA, ICH, CPMP, GCPs, company standards, policies, and principles of medical research.

• Excellent communication, interpersonal, organizational, teamwork, and negotiation skills.

• Capacity to influence others within teams and matrix environments.

• Experience in a pharmaceutical company is preferred.

• Clinical and/or research experience in neuroscience, neurodegeneration, and/or pain research is preferred.

• Comprehensive clinical pharmacology experience is preferred.

• Familiarity with genetic therapy modalities such as siRNA, ASO, and gene therapy is preferred.

• Additional scientific training or degree (M.S., Ph.D.) is preferred.

🏝️ Benefits

• Company bonus based partly on individual and company performance.

• Company-sponsored 401(k).

• Pension plan.

• 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 an employee assistance program, fitness benefits, and employee clubs and activities.

• Employee resource groups (ERGs).

• Disability accommodation support during the application process.