Director - Clinical Design Physician - Cardiometabolic Health

Primary Responsibilities

• Translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.
• 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.

Scientific Data Dissemination/Exchange

• 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.
• Participate in development of scientific data dissemination, and preparation of final reports and publications.

Scientific / Technical Expertise

• Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.
• Be aware of current trends and projections for clinical research, and practice, and access in the therapeutic area(s) relevant to the product.
• Engage appropriately with the asset teams on relevant external activities to have good understanding of their patients, medical and payer communities, and business strategy.

Shared Learning

• Focus on organizational learning to identify best practices, delivering these as systemized standard approaches with ultimate goal to make program and protocol design streamlined, less burdensome, faster, and less expensive.
• Closely collaborate with asset teams and execution teams to understand the impact of design on speed to protocol approval and study startup.
• Work over time with other Clinical Design staff to analyze experience and improve approaches.
• Work closely with counterparts in Clinical Design and therapeutic areas to continue to evolve Lilly standards, tools, and best practices that span drug development.
• Provide clinical leadership in collaboration with other Clinical Design members in appropriate development of standardized/simplified processes, templates, and tools.