Clinical Research Scientist-Clinical Design Neuroscience

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 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.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $294,800.Clinical Design Scientist – Clinical DesignPurpose : Clinical Design provides clinical program and trial design leadership and expertise within Eli Lilly – designing novel clinical programs to answer scientific questions, align with the corporate and asset strategies, and enable delivery. The value proposition is achieved by applying design excellence competencies and principles related to value-based research, data-driven decisions, and accelerated delivery. Clinical Design leverages internal and external information within and across therapeutic areas to provide modern, innovative solutions to Lilly’s drug development needs.The purpose of the Clinical Design Scientist is to provide Medical and scientific leadership in the clinical program and trial design of assets approaching and / or primarily in Phases II to IV. In order to accomplish this, the Clinical Design Scientist must have a deep understanding of the biopharmaceutical industry, drug development process, the therapeutic area that is relevant for the programs in development, clinical research, and clinical program and study design. Thus, the Clinical Design Scientist provides scientific, clinical, and therapeutic expertise / application, and leadership in the creation of program and trial designs that can be executed.The Clinical Design Scientist may be called upon to participate on additional items including but not limited to protocols, publications, regulatory interactions, internal executive and governance presentations, external key opinion leader interactions, medical outreach / advocacy, and industry conferences.Primary Responsibilities : Clinical Plan Options and Clinical Trial ProtocolsAs the Medical leader on a cross-functional Clinical Design team, translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s).Bring the medical / clinical perspective to the Design Team to inform the design of study protocols and in partnership with the other functions.Provide insight into impact of study / protocol design features to feasibility, value, patient and investigator burden, and execution speed / efficiency.Contribute to the development of asset strategy in partnership with the asset team.Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.Clinical Research / Trial Packages, Execution and SupportCollaborate and complement clinical research staff in the design and conduct of clinical trials.Understand how design elements influence the ability to deliver on new regulatory expectations.Review risk profiles to ensure appropriate communication of risk to study subjects via the protocol.Support investigator identification and selection, in conjunction with Clinical Development.Partner with Clinical Development to accelerate participant recruitment and retention efforts.Support seamless transition of protocols from design to execution.Scientific Data Dissemination / ExchangeEstablish and maintain appropriate collaborations and relationships with external experts and the general medical community.Participate in development of scientific data dissemination and preparation of final reports and publications related to assets.Scientific / Technical ExpertiseCritically read, evaluate, and apply the relevant medical literature and data from competitive products.Engage appropriately with the asset teams and the business unit development teams.Shared LearningFocus on organizational learning to proactively identify, apply, and share best practices related to program and protocol design.Work closely with counterparts in Clinical Design and therapeutic areas to continue to evolve Lilly standards, tools, and best practices.Minimum Qualification Requirements : A relevant, advanced health / medical / scientific degree, or a related, relevant graduate degree such as DVM, PharmD, PhD, or MSN with advanced clinical specialty.Pharmaceutical Industry experience, or similar, of at least three (3) years that provides adequate background relevant to clinical trial design of PhII to Phase IV studies.or4-year bachelor’s or master’s degree in a health / medical / scientific discipline and Pharmaceutical Industry experience, or similar, of at least seven (7) years.Additional Preferences : Clinical research experience in the therapeutic area.Strong understanding of therapeutic area pathology, pathophysiology, unmet needs, and treatment standards.Strong foundation in statistical science, including Bayesian statistics, as applied to study design.Global / multi-national design or development experience.MBA or similarly relevant training.Willing to relocate to Indianapolis or work effectively from a remote location.Fluent in English, with strong communication skills.Strong interpersonal, organizational, and negotiation skills.Ability to influence others to advance objectives.Other Information : Primary internal interactions : Clinical Design and Development teammates and leadershipTeam leaders and COOsSr. Leaders within Clinical, R&D, therapeutic areas, and business unitsExternal Contacts : Scientific and clinical experts, thought leadersPracticing physicians / prescribersRegulatory agency personnelLilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.Lilly is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.Our employee resource groups (ERGs) offer strong support networks for their members. Learn more about all of our groups.Full-time equivalent employees also will be eligible for a company bonus. In addition, Lilly offers a comprehensive benefit program to eligible employees.#WeAreLilly#J-18808-Ljbffr

Salary : $168,000 - $294,800