Director - Clinical Design Physician – Cardiometabolic Health

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the globe, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the world take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

About the Role

The Clinical Design function was created 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 Director - Clinical Design Physician – Cardiometabolic Health provides medical leadership within the group. This role requires deep understanding of the biopharmaceutical industry, drug development, diabetes-associated comorbidities, clinical research, and clinical study design. The Director plays a key role in developing program and trial design options and translating them into high-quality clinical trial protocols, primarily focusing on proof of concept and registration clinical studies but may also work across early and late phases of development and commercialization.

Responsibilities

• Translate therapeutic area and asset team strategy into clear objectives and clinical development program and trial optionality, addressing business and customer needs (patient, prescriber, payer, and/or regulator).
• Represent program and trial design optionality to asset teams and senior leaders to inform prioritization and adjust based on feedback.
• 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 the impact of study/protocol design features on execution speed and efficiency.
• Contribute to asset strategy (e.g., identification of target patient population) and business unit/global alignment of portfolio clinical strategy.
• Collaborate with clinical research staff on trial design and conduct (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, subject recruitment, diversity, and retention efforts.
• Support seamless transition of protocols from design to execution.
• Comply with local laws, regulations, and global policies regarding data dissemination and interactions with external healthcare professionals.
• Establish and maintain collaborations with external experts, thought leaders, and the medical community.
• Participate in the development of scientific data dissemination, final reports, and publications.
• Critically evaluate medical literature, competitive product data, and scientific developments relevant to the product.
• Engage with asset teams on external activities to understand patients, medical and payer communities, and business strategy.
• Focus on organizational learning to identify best practices and streamline program and protocol design.
• Collaborate with asset and execution teams to improve speed to protocol approval and study startup.
• Provide clinical leadership in developing standardized processes, templates, and tools.

Requirements

• Medical Doctor (MD) or Doctor of Osteopathy (DO).
• Board eligible or certified in an appropriate specialty/subspecialty or equivalent post-medical school clinical training.
• U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S.-based roles may be hired at the discretion of the Chief Medical Officer if not U.S. board eligible or certified.
• Non-U.S. trained physicians must have completed education and training at a medical school meeting Liaison Committee on Medical Education (LCME) requirements.
• Minimum of three years of pharmaceutical industry experience, providing strong grounding in drug development, clinical trial principles, and scientific decision-making.
• Minimum of three years of 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).

Preferred Qualifications

• Clinical trial design leadership in at least one key development phase (proof of concept, dose ranging, registration, and/or phase 3b/4 studies).
• Board certification or eligibility in a specialty directly relevant to comorbidities of diabetes (e.g., cardiology, obesity medicine, nephrology, hepatology).
• 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 cross-functional teams to advance business strategies and objectives.
• Excellent teamwork and 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 execution and a bias for simplifying processes.
• Strong communication skills demonstrated across various modalities (e.g., presentations, meetings, protocols, regulatory documents) and stakeholders (e.g., senior leaders, medical/non-medical counterparts, thought leaders, investigators, regulators).
• Bias for action and desire to influence a broad portfolio through exceptional clinical plan optionality and study design.
• MBA or 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, critical success factors).
• Ability to communicate effectively with statisticians and translate complex principles for design optionality and protocols.
• Willingness to relocate to Indianapolis or demonstrated ability to work effectively remotely in a hybrid environment.
• Willingness to travel domestically and internationally for business-critical events, teambuilding, and networking.

Internal and External Interactions

Primary internal interactions: Clinical Design teammates and leadership, clinical planning and operations teams, statisticians, scientific communication associates, health outcomes research consultants, regulatory directors, product directors, legal counsel, therapeutic area physicians, and global marketing.

External contacts: Scientific and clinical experts, thought leaders, Lilly clinical investigators, practicing physicians/prescribers, regulatory agency personnel, professional association staff, disease advocates, and formulary representatives.