The Clinical Design function was created 6 years ago within Eli Lilly to establish study design as a core capability, with tightly integrated cross-functional experts providing innovative, high-quality study designs that transition seamlessly to execution. The purpose of the Clinical Design Physician role is to provide Medical leadership within the group. The Clinical Design Physician must have deep understanding of the biopharmaceutical industry, drug development, Diabetes-associated comorbidities, clinical research, and clinical study design.
Through application of Industry training, clinical expertise, and relevant experience, the Clinical Design Physician plays a key role in the development of program and trial design options and translation into high quality clinical trial protocols. While Clinical Design’s main focus is on proof of concept and registration clinical studies, Clinical Design Physicians may work on trials across early and/or late phases of development and commercialization of the product. Clinical Design Physicians may participate in the authoring and/or review process for publications and as needed works with regulatory and other governmental agencies. Clinical Design Physicians will participate, at times, in activities largely led by Asset Teams, such as outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
Primary Responsibilities
The primary responsibilities of the Clinical Design Physician – Diabetes Comorbidities are generally related to phase II (proof of concept) to III (registration) studies in patients with commonly occurring comorbidities of diabetes (e.g. obesity, cardiovascular disease, renal and hepatic complications). The core job responsibilities typically include those listed below as well as all other duties as assigned.
Clinical Plan Options and Clinical Trial Protocols
- 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 Diabetes and Obesity 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.
Clinical Research/Trial Packages, Execution and Support
- 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.
Minimum Qualification Requirements:
- MD/DO
- Industry experience in of at least three years and adequate to provide strong grounding in the drug development progress, clinical trial principles, and scientific decision-making.
- Experience of a minimum of 3 years 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).
- Clinical trial design leadership in at least one key in scope development phase (proof of concept, dose ranging, registration, and/or phase 3b/4 studies).
Additional Preferences:
- Board certification or eligibility within a specialty directly relevant to comorbidities of Diabetes (e.g. cardiology, obesity medicine, nephrology, hepatology) strongly preferred
- Clinical research 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).
- Understanding of how design elements translate into delivery. Bias for simplifying, reducing burden, and creation of value through excellent design.
- 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.
- 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, teambuilding, 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.
