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 world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe 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 role provides medical leadership within the group. The 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 Director 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, the role may work on trials across early and/or late phases of development and commercialization of the product. The Clinical Design Physician may participate in the authoring and/or review process for publications and, as needed, works with regulatory and other governmental agencies.

They will participate 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.

Responsibilities

• Translate therapeutic area and asset team strategy into clear objectives and associated 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 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 the impact of study/protocol design features on 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 of 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.
• 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 the 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, practice, and access in the therapeutic area(s) relevant to the product.
• Engage appropriately with asset teams on relevant external activities to understand patients, medical and payer communities, and business strategy.
• Focus on organizational learning to identify best practices, delivering these as systemized standard approaches to streamline program and protocol design, reduce burden, and improve speed and cost efficiency.
• Collaborate with asset teams and execution teams to understand the impact of design on speed to protocol approval and study startup.
• Work with other Clinical Design staff to analyze experience and improve approaches.
• Collaborate with counterparts in Clinical Design and therapeutic areas to evolve Lilly standards, tools, and best practices that span drug development.
• Provide clinical leadership in collaboration with other Clinical Design members in the development of standardized/simplified processes, templates, and tools.

Requirements

• Medical Doctor (MD) or Doctor of Osteopathy (DO).
• Must be board eligible or certified in an appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S.-based jobs who are not U.S. board eligible or certified may be hired at the discretion of the Chief Medical Officer.
• Non-U.S. 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 of at least three years, providing strong grounding in drug development progress, clinical trial principles, and scientific decision-making.
• Minimum of 3 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 in-scope development phase (proof of concept, dose ranging, registration, and/or phase 3b/4 studies).
• Board certification or eligibility within 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 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, with a bias for simplifying, reducing burden, and creating 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 a broad set of stakeholders (e.g., team leaders, senior leader decision makers, medical and non-medical counterparts, thought leaders, investigators, regulators).
• 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, team building, and to develop a strong internal network.
• Willing to engage in limited domestic and international travel to support the business of the team.

Key Interactions

Internal: Clinical Design teammates and leadership, clinical planning, operations, CRPs/Ss, other research staff, team leaders and COOs, senior leaders within Clinical, R&D, therapeutic areas, and business units, statisticians, scientific communication associates, health outcomes research consultants/research scientists, regulatory directors, scientists, and associates, product directors, managers, and associates of the brand teams, legal counsel, therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and senior medical leaders, global marketing director or manager, corporate patient safety.

External: Scientific and clinical experts, thought leaders, Lilly clinical investigators, practicing physicians/prescribers, regulatory agency personnel, professional association staff and leaders, disease advocates and lay organizations focused on relevant health issues, formulary representatives (private and government).