Medical Director - Clinical Development (Design Hub)
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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
Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates who are not U.S. board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
At least 5 years of clinical research and/or pharmaceutical medicine experience. Ideally this experience will have accrued in an industry or academic setting.
Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).
Deep understanding and clinical research experience of immunology therapeutic area – pathology, pathophysiology, unmet needs, and treatment standards. Board certification or eligibility within immunology is strongly preferred.
Expertise in one or more areas relevant to clinical trial design are strongly preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc.).
Experience in writing and conducting Phase-2 and Phase-3 studies
Fluent in English; both written and verbal communications
Social, organizational, and negotiation skills
Ability to influence others (both cross-functionally and within the function) to create a positive working environment.
Willing to relocate to Indianapolis.
Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status