Director, Medical - Clinical Research Scientist

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. The Cardiometabolic Research (CMR) Program Clinical Research Scientist (CRS) participates in the following for compounds of responsibility for the therapeutic area, including an evolving portfolio of compounds targeting women’s health: 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; assessment of licensing opportunities, and the outreach activities aimed at the external clinical customer community. In addition, the Clinical Research Scientist works with research scientists to identify lead compounds and clinical candidates and plan pre-clinical studies. Core tasks will be delegated based on level of experience. Other activities include internal training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. The primary responsibilities of the CMR Program Phase CRS are generally related to early-phase compounds, including those targeting women’s health. 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. Support preparation of high-level plan for phase Ill studies. Collaborate with local clinical research staff, consultants and clinical investigators in the design, conduct and reporting of global Phase lb and Ila/IIb clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions). 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. Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development. Collaborate with non-clinical pharmacologists to translate observations from animal experiments to human clinical studies (biomarker development) in the area therapeutic area of responsibility. Collaborate with drug disposition scientist to conduct pharmacokinetic and drug metabolism studies of drug candidates in humans. Assist pharmacokineticists and statisticians by providing clinical support to the development of pharmacostatistical models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens and selection of the target patient population. Clinical Research/Trial Execution and Support Design and oversee implementation of Phase lb and Ila/IIb clinical studies. Design and write clinical trial protocols. Design and oversee implementation methods for development and biomarker qualification studies. 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 clinical team. Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials (Phase I and II). Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. Ensure 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 CDAs I 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 corporate patient safety policies and procedures. 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. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination and preparation of final reports. Support development of slide sets and publications (abstracts, posters, manuscripts). Support the creation and review of any scientific information with respect to customer questions or media request in accordance with global compliance policies and procedures. Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response. Develop and review labeling modifications in collaboration with regulatory and safety groups. Participate in risk management planning along with GPS colleagues.</li