Clinical Research Physician - Malignant Hematology

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.  Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Physician (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. Core Job Responsibilities The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds.    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 the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design. Contribute to business unit and 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 ICDs 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