Director - Clinical Design Physician - Cardiometabolic Health

About the role

The Director - Clinical Design Physician - Cardiometabolic Health at Eli Lilly and Company is responsible for translating therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality. This role involves representing program and trial design optionality to asset teams and senior leaders, developing study protocols, and contributing to the development of asset strategy.

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 senior leaders to inform prioritization of an option that will be translated into a clinical protocol(s).
• 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.
• 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.
• Participate in development of scientific data dissemination, and preparation of final reports and publications.
• 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.
• 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.

Requirements

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• Pharmaceutical Industry experience in multiple areas relevant to clinical trial design (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).

Preferences

• Experience of a minimum of 3 years in multiple areas relevant to clinical trial design.
• Board certification or eligibility within a specialty directly relevant to comorbidities of Diabetes (e.g., cardiology, obesity medicine, nephrology, hepatology) strongly preferred.
• Experience in one or more comorbidities of Diabetes.
• Strong understanding of relevant comorbidities of Diabetes – pathology, pathophysiology, unmet needs, and treatment standards.
• Strong interpersonal, organizational, and negotiation skills.
• Ability to influence others (both cross-functionally and within the function) to advance business strategies and objectives.
• Excellent teamwork skills.
• Fluent in English, with strong communication skills, verbal and written.
• Drug development experience spanning all core relevant phases (proof of concept through registration).
• Bias for action.
• Desire to influence a broad portfolio across phases through exceptional clinical plan optionality and study design.
• MBA or similarly relevant training in the business of life sciences.
• 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.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).