Are you seeking a career that makes a difference in the world? We are pursuing a new Clinical Research Physician on our Immunology Team who has deep understanding of Immunology and clinical study design and research. Clinical Research Physicians are key scientific leaders within our Design Hub. The Design Hub seeks to deliver a core clinical design capability with tightly integrated cross-functional expertise to provide consistent, high quality designs to asset teams.
As a Clinical Research Physician (CRP) in our Design Hub, you will play a key role in the development of global clinical trials by providing scientific, clinical, and therapeutic expertise and leadership. While the Design Hub's initial focus is on proof of concept and registration clinical studies, you may work on trials across early and/or late phases of development and commercialization of the product. You may also participate in the review process for protocols and publications, and as needed, work with regulatory and other governmental agencies. There will also be opportunities for you to join in activities such as outreach medical activities aimed at the external clinical customer community, the formation and implementation of the global strategy for the product, and various medical activities in support of demand realization.
Sound interesting to you? Are you ready to bring your skills and talents to Lilly? Read on to find out more about the CRP responsibilities and how you can join Team Lilly. Clinical Planning and Clinical Trial Protocols
Lead efforts to design/develop clinical study protocols aligned with the product lifecycle plan and clinical strategy to address key customer needs (patient, regulator, prescriber, and/or payer).
Cooperate with the BioMedicines Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and design of the protocols.
Partner with the Asset Team Senior Director/Senior Medical Director to approve protocols.
Provide clinical leadership and insight to Design Hub activities, bringing systematic consideration of impact to execution speed/efficiency in the design of protocols and clinical trial packages.
Lead development of optimized design and execution elements in clinical plans that deliver high quality, cost-efficient clinical development outcomes and provide expert consultation to teams in development of their clinical program plans.
Closely collaborate with the asset teams and their external activities to maintain a good understanding of their patients, medical and payer communities, and business strategy.
Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.
Clinical Research/Trial Packages, Execution and Support
Collaborate with clinical research staff with the design and conduct of clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
Review risk profiles to ensure appropriate communication of risk to study subjects.
Participate in investigator identification and selection.
Support transition of protocols from design to execution.
Scientific Data Dissemination/Exchange
Provide knowledge of and compliance with local laws and regulations and global policies and procedures with respect to data dissemination and interactions with external health care professionals.
Establish and maintain appropriate collaborations and relationships with external authorities, professional societies, and the general medical community.
Participate in developing scientific data and preparation of final reports and publications.
Scientific / Technical Expertise and Shared Learning
Critically read and evaluate medical literature. Know the status and data from competitive products. Keep updated with medical and other scientific developments.
Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s).
Focus on organizational learning to identify standard methodologies, delivering these as systemized standard approaches with ultimate goal to make program and protocol design faster and less expensive. This will require cross-TA sharing within the hub and structured efforts to understand and benefit from our repeated, ongoing experiences.
Work closely with counterparts in other TAs to continue to evolve Lilly standards, tools and processes across development.
Actively participate in subject recruitment, diversity, and retention efforts
Internal Number: 48195
About Eli Lilly & Company
Company Overview 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 39,000 employees worldwide 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.