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.

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