Clinical Design Physician Neuroscience (M.D.)

About the Role

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. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

Responsibilities

• Clinical Plan and Trial 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.
  • Address business and customer needs (patient, prescriber, payer, and/or regulator) in alignment with the phase of the product lifecycle, clearly articulating tradeoffs in value (data generated, risks created/discharged, cost, and time).
  • 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). Adjust optionality based on feedback.
  • Bring the medical/clinical perspective to the Design Team to inform the design of study protocols in partnership with other functions (e.g., Asset Team, BU Development Team).
  • Provide insight into the impact of study/protocol design features on 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 associated asset-specific clinical plans, including main indication and line extensions.
• Clinical Research/Trial Packages, Execution and Support
  • 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).
  • Understand how design elements influence new regulatory expectations (e.g., decentralization of clinical trials, increased racial and ethnic diversity) 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, especially considering how design elements can create value in these areas.
  • Support seamless transition of protocols from design to execution.
• Scientific Data Dissemination/Exchange
  • Ensure knowledge of and compliance with local laws and regulations, global policies and procedures, and compliance guidelines regarding data dissemination and interactions with external healthcare professionals.
  • Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
  • Develop and maintain collaborations with relevant professional societies, conferences, and consortia.
  • Participate in the 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.
• Scientific / Technical Expertise
  • Critically read, evaluate, and apply relevant medical literature, competitive product data, and updates with medical and scientific developments in the therapeutic area, disease state, and product.
  • Stay 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 and business unit development teams on relevant external activities to understand patients, medical and payer communities, and business strategy.
  • Apply the above to recommended clinical program and trial optionality and when supporting other medical-related areas as assigned.
• Shared Learning
  • 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.
  • 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 evolve Lilly standards, tools, and best practices that span drug development.
  • Provide clinical leadership in collaboration with other Clinical Design members to develop standardized/simplified processes, templates, and tools.

Requirements

• Medical Doctor or Doctor of Osteopathy.
• Must be board eligible or certified in a relevant field or have completed comparable 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 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 providing adequate background relevant to clinical trial design of Phase II 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).

Skills & Preferences

• 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).
• 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 effectively from a remote location in a hybrid environment.
• Willing to travel for business-critical events and to develop a strong internal network, including limited domestic and international travel.
• Fluent in English, with strong verbal and written communication skills.
• 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, with a bias for simplifying, reducing burden, and creating value through excellent design.
• Strong communication skills demonstrated in various modalities (e.g., presentations, meetings, creation of protocols and regulatory documents) and with a broad set of stakeholders (e.g., team leaders, senior leaders, medical and non-medical counterparts, thought leaders, investigators, regulators).
• Experience routinely using AI to accelerate deliverables.

Internal & External Interactions

• Primary internal interactions: Clinical Design and Development teammates and leadership, clinical planning, clinical capabilities, research staff, team leaders, COOs, senior leaders within Clinical, R&D, therapeutic areas, and business units, statisticians, scientific communication associates, health outcomes research consultants, regulatory directors, product directors, legal counsel, therapeutic area physicians, pricing/access/reimbursement, new product planning, global marketing, global patient safety.
• External contacts: Scientific and clinical experts, thought leaders, Lilly clinical investigators, practicing physicians/prescribers, regulatory agency personnel, professional association staff and leaders, disease advocates, lay organizations focused on relevant health issues, formulary representatives (private and government).

Benefits

Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities when vying for positions. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN), and Women’s Initiative for Leading at Lilly (WILL).

Pay

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $356,400 annually.