Clinical Design Physician Neuroscience (M.D.)

Eli Lilly and Company • Indianapolis, IN

1d • Hybrid

About The Position

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 employees around the world 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. Organization Overview 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.

Requirements

• Medical Doctor or Doctor of Osteopathy.
• Must be board eligible or certified in Oncology or Hematology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• US trained physicians must have achieved board eligibility or certification.
• Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
• 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).
• 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).

Nice To Haves

• Board certification or eligibility within Neuroscience or related area strongly preferred.
• Clinical research experience in the therapeutic area
• Strong understanding of therapeutic area pathology, pathophysiology, unmet needs, and treatment standards in major geographies (e.g. US, EU, Japan, China, etc).
• Strong foundation in statistical science, including Bayesian statistics, as applied to study design (e.g., sample size determination, setting of critical success factors).
• Ability to communicate effectively with statisticians and help translate complex principles to inform design optionality and protocols.
• 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.
• Willing to travel for business-critical events and to develop a strong internal network.
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English, with strong communication skills, verbal and written.
• Strong interpersonal, organizational, and negotiation skills.
• Ability to influence others (both cross-functionally and within the function) to advance objectives.
• Understanding of how design elements translate into delivery.
• Bias for simplifying, reducing burden, and creation of value through excellent design.
• Strong communication skills demonstrated in a variety of modalities (e.g. presentations, meetings, creation of protocols and regulatory documents) and with broad set of stakeholders (e.g. team leaders, Sr. Leader decision makers, medical and non-medical counterparts, thought leaders, investigators, regulators).
• Experience routinely using AI to accelerate deliverables

Responsibilities

• 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 (data generated, 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.
• 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). Provide insight into impact of study/protocol design features to feasibility, value, patient and investigator burden, and 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 including main indication and line extensions.
• Collaborate and complement clinical research staff in the design and conduct of clinical trials (e.g. sample size, patient commitment, timelines, grants, and governance review interactions).
• Understand how design elements influence the ability to deliver on new regulatory expectations (e.g. decentralization of clinical trials, increase racial and ethnic diversity in clinical trials) and clinical capabilities (e.g. value-based, patient accessibility, patient burden).
• Review risk profiles to ensure appropriate communication of risk to study subjects via the protocol.
• 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.
• 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.
• 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.
• Apply the above to the optionality recommended for clinical programs and trials and when supporting other medical-related areas as assigned.
• 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.
• Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup.
• Identify and participate in opportunities 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree