Medical Director, Genetic Medicines

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. At Lilly, we unite caring with discovery to make life better for people around the world. Lilly Regenerative Medicine (LRM) carries out this mission ambitiously, utilizing some of the most cutting-edge science to deliver therapies that address the root cause of disease for patients living with sensory disorders, genetic diseases and rare diseases. Our work is driven by a singular commitment: to transform the lives of patients who have had too few options for too long. Our current portfolio is focused on the development of gene therapy programs for the treatment of sensory disorders, ranging from ultra-rare diseases to prevalent conditions, from preclinical to registration stage programs, all with the intent to address significant unmet medical need and bring transformative benefits to patients. Gene therapy is redefining what medicine can be: single-administration treatments with the potential to durably alter — or cure — the course of disease. Programs in this space rarely wait. Phases of clinical development can compress, blend, and even overlap; and administration can require the use of medical devices. Purpose: Lilly Regenerative Medicine is seeking a highly motivated and experienced Clinical Research Physician (CRP) to join our Gene therapy Medical Development function. This role will be instrumental in the clinical development of innovative gene therapies for sensory and rare disorders, contributing to study design, execution, and interpretation of clinical trial data. Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the CRP participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; 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, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource for study teams, departments, and others as needed. The CRP must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance’s (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision. Primary 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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Core Job Responsibilities: The primary responsibilities of the Development CRP are generally related to early-phase and also late-phase assets. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Clinical Planning • Collaborate with Discovery; contribute to global alignment of clinical strategy and clinical plans. • Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Clinical Research/Trial Execution and Support • Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline • Provides oversight and input into clinical development plan • Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). • Review and approve risk profiles to ensure to ensure appropriate communication of risk to study subjects. • Participate in investigator identification and selection, in conjunction with clinical teams. • Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, 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 operations personnel / 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. • 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. • Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. • Support medical information associates in preparation and review of medical letters and other medical information materials. • Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). • Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis. • Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel. • Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in