Are you seeking a career that makes a difference in the world? We are pursuing a new Medical Director on our Immunology Team who has deep understanding of Immunology and clinical study design and clinical research. Medical directors 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 Medical Director 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.
Does this sound interesting to you? Are you ready to bring your skills and talents to Lilly? Please read on to find out more about the responsibilities of the Medical Director and how you can join Team Lilly. Clinical Planning and Clinical Trial Protocols
Lead efforts in optimizing clinical study design incorporating adaptive design features into clinical studies which may impact the duration, speed or cost of the study
Lead efforts in writing 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 preclinical, clinical pharmacology, regulatory affairs, clinical development and marketing teams to ensure tight strategic integration of the product development plan.
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., patient commitment, schedule of events, timelines, and governance review interactions).
Have a basic understanding of biostatistics to allow effective interaction with biostatisticians
Support transition of protocols from design to execution.
. 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.