Director - Clinical Research Scientist

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.Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking a Senior Director -  Clinical Research Scientist (CRS) to help lead clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in collaboration with the Clinical Research Physician and cross-functional leadership driving clinical strategy, regulatory alignment, and program execution, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and direct biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external partners.Responsibilities: The primary responsibilities of the Verve Senior Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease.The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, mentorship (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.The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.Clinical PlanningHelp lead the development and execution of the global clinical development strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions.Collaborate with clinical pharmacologists and statisticians while providing scientific leadership to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to inform program-level decisions and optimize development strategyClinical Research/Trial Execution and SupportDevelop and coordinate implementation of Phase lb and Ila/IIb clinical studies.Compose and write clinical trial protocols.Collaborate on investigator identification and selection while influencing site strategy at a program level, in conjunction with clinical team.Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials with accountability for execution, quality, and timelines.Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects.Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studiesReview, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and translate findings into strategic program decisionsPartners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactionsLeads cross-functional and key decision making meetings to review topics and develop mitigation plansAssist in planning process and engage 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 research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.Scientific Data Dissemination/ExchangeSupport the planning of symposia, advisory board meetings, and other meetings with health care professionals.Engage in data analysis, development of scientific data dissemination and preparation of final reports.Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studiesRepresent the company as a scientific leader in providing congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet leaders with vision, and engage in customer events).Regulatory Support ActivitiesSupport/direct in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolve regulatory issues, including regulatory response.Business/ customer supportEstablish and maintain appropriate collaborations and relationships with external experts, leaders with vision, and the general medical community on a national and possibly international basis.Scientific & Technical Expertise and Continued DevelopmentUnderstand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule.Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic areaKnowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects.Attend scientific symposia.Influence portfolio strategy and cross-program alignment through senior leadership engagementOther activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consu