Associate Vice President - Early Development Clinical Research Physician - Neuroscience

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose and Role Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline. The ideal candidate will have expertise in neuroscience drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas. The Clinical Research Physician (CRP) will be the clinical lead to progress multiple early clinical assets into first-in-human studies and support their further development through the conduct of clinical pharmacology and mechanistic studies. Through the application of scientific and medical training, the CRP participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders. The CRP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed. Basic Qualifications 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 that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer. At least ten (10) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of first-in-human and biopharmaceutical Phase 1 (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management). Additional Skills/Preferences Pharmaceutical company experience preferable. Clinical and/or research experience in neuroscience, neurodegeneration, and/or pain research preferable. Broad experience in Clinical Pharmacology preferable. Experience with genetic therapy modalities (e.g., siRNA, ASO, gene therapy) preferable. Additional scientific training or degree (M.S., Ph.D.) preferable. Fluent in English; both written and verbal communications. Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills. Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%). Core Job Responsibilities The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission. Support preparation for first-in-human dosing studies including biomarker plans. Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical plan to support submission. Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies. Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models. Contribute, as an integral member of the Exploratory Medicine and Pharmacology team, to global Phase 1 clinical studies as well as submission planning activities. Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development. Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharmaceutical submission plan. Clinical Research/Trial Execution and Support Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations. Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research. Design and oversee implementation methods for development and biomarker qualification studies. Design, create, and provide oversight for protocol development. Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements. Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements. Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group. Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects. Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures. Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety. Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health-care professionals/customers. Address the unsolicited scientific questions and information needs of external health-care professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process. Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies. Publish results of research projects as appropriate. Consider, review, or develop pharmaco #J-18808-Ljbffr