Director - Clinical Design Physician - Cardiometabolic Health

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 serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

• As the Medical leader on a cross-functional Clinical Design team, translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality. Optionality will address business and customer needs (patient, prescriber, payer, and/or regulator); be in alignment with phase of product lifecycle; and clearly articulate associated tradeoffs in value (information gathered, risks created/discharged, cost, and time).
• Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s). Adjust optionality in accordance with feedback from leadership.
• Develop study protocols in collaboration with the Design Team and partners in the Lilly Cardiometabolic Health Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology.
• Provide insight into impact of study/protocol design features to execution speed/efficiency.
• Contribute to the development of asset strategy (e.g. identification of target patient population) in partnership with the asset team.
• Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.

• Collaborate with clinical research staff in the design and conduct clinical trials (e.g. sample size, patient commitment, timelines, grants, and governance review interactions).
• Champion key strategic initiatives, such as decentralized clinical trials and diversity/equity/inclusion in clinical research. Understand how design elements influence the ability to deliver on these initiatives and influence adoption of designs that enable their success.
• Review risk profiles to ensure appropriate communication of risk to study subjects.
• Participate in investigator identification and selection, in conjunction with Clinical Design and clinical teams.
• Actively participate in subject recruitment, diversity, and retention efforts.
• Support seamless transition of protocols from design to execution.

• 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.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Partici…