Clinical Design Physician Neuroscience (M.D.)

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).
• Bring the medical/clinical perspective to the Design Team to inform the design of study protocols and in partnership with the other functions (e.g. Asset Team, BU Development Team).
• Contribute to the development of asset strategy (e.g., identification of target patient population) in partnership with the asset team.
• Support investigator identification and selection, in conjunction with Clinical Development.
• Partner with Clinical Development to accelerate participant recruitment and retention efforts – especially considering how design elements can create value in these areas.
• Support seamless transition of protocols from design to execution.
• Knowledge of and compliance with local laws and regulations, global policies and procedures, and 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.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies, conferences, and consortia.
• Participate in development of scientific data dissemination and preparation of final reports and publications related to assets and/or support efforts to influence clinical design science within the industry.

Scientific Data Dissemination/Exchange

• Engage appropriately with the asset teams and the business unit development teams on relevant external activities to have good understanding of their patients, medical and payer communities, and business strategy.

Scientific / Technical Expertise

• Critically read, evaluate, and apply the relevant medical literature, status and data from competitive products, and updates with medical and other scientific developments relevant to the therapeutic area, disease state, and product.
• Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to the product.
• Apply the above to the optionality recommended for clinical programs and trials and when supporting other medical-related areas as assigned.

Shared Learning

• Focus on organizational learning to proactively identify, apply, and share best practices and learnings related to program and protocol design within and outside the organization.
• 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.

Basic Qualification Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in relevant field or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• Pharmaceutical Industry experience or research experience of at least three (3) years that provides adequate background relevant to clinical trial design of PhII to Phase IV studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).

Additional Skills/Preferences:

• Board certification or eligibility within Neuroscience or related area strongly preferred.
• Global / multi-national design or development experience.
• Willing to relocate to Indianapolis. If unable to relocate, demonstrated ability to work with high effectiveness from a remote location in a hybrid environment.
• Experience routinely using AI to accelerate deliverables.