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Executive Medical Director – Early Clinical Development, Immunology
Eli Lilly and CompanyExecutive Medical Director guiding early clinical development for Immunology at Lilly. Bridging discovery science and clinical application for transformative patient therapies.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Collaborate with discovery, translational medicine, and clinical teams to develop and refine therapeutic hypotheses for autoimmune and inflammatory diseases
- Participate in prioritization of target and modality selection, integrating scientific rigor with clinical feasibility, unmet needs, and commercial potential, with particular attention to transformational potential of proposed programs
- Evaluate and diligence external discovery and early clinical opportunities for potential partnerships or acquisitions
- Provide scientific and clinical expertise to portfolio strategy to ensure a robust pipeline of transformational medicines in autoimmunity and inflammation
- Act as a visible strategic leader within the immunology portfolio, influencing direction, investment decisions, and development priorities
- Design early clinical studies that efficiently test therapeutic hypotheses
- Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other stakeholders to optimize study design and execution
- Integrate translational endpoints and biomarker strategies to accelerate and maximize learning from early clinical studies and enable early decision-making
- Contribute to regulatory interactions, including pre-IND, IND submissions, interactions to ex-US health authorities, as well as regulatory strategy development
- Monitor patient safety and ensure compliance with GCP, FDA, ICH guidelines, and company policies
- Drive innovative experimental medicine approaches and accelerate progression from first-in-human through proof-of-concept
- Serve as scientific and medical expert across multiple therapeutic programs simultaneously
- Lead early clinical strategy in cross-functional teams through matrix influence, aligning diverse stakeholders around common objectives
- Facilitate decision-making processes across discovery, development, and commercial functions
- Mentor and develop junior team members while building scientific capabilities across the organization
- Operate as a culture-shaping leader who elevates performance, accountability, and collaboration across teams
- Establish and maintain relationships with key opinion leaders and scientific experts in autoimmunity and inflammation
- Represent Lilly at scientific conferences, advisory boards, and industry forums
- Support business development activities through clinical scientific due diligence
- As appropriate, identify, evaluate, and execute strategic partnerships with CROs, biotech companies, academic institutions, and research organizations to enable the discovery and early development portfolio and strategy
- Enhance Lilly’s external scientific presence as a thought partner and collaborator in immunology innovation
- Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning
- Contribute medical expertise to regulatory submissions and agency communications
- Support risk management planning and safety signal evaluation
- Participate in data analysis, scientific publications, and medical communications
- Help shape development strategy and regulatory positioning for early-stage immunology assets
Requirements
What you’ll need- Medical Doctor or Doctor of Osteopathy
- Must be board eligible or certified in Rheumatology, Dermatology, Gastroenterology, Allergy/Immunology, or related specialty or have completed the comparable level of 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 directly for employment in the US 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)
- Minimum 3–5+ years of pharmaceutical/biotechnology industry experience with progression to Director or Sr Director responsibilities in early clinical development
- PhD in Immunology, Molecular Biology, or related field strongly preferred
- Demonstrated experience in early-phase clinical trial design and execution
- Strong background in translational medicine and biomarker development or application
- Track record of successful cross-functional collaboration and matrix leadership
- Deep understanding of immunology, autoimmune disease pathophysiology, and current therapeutic landscape
- Experience with novel immunomodulatory approaches (biologics, small molecules, cell therapies, genetic medicines)
- Knowledge of regulatory requirements for early clinical development (IND strategy, FDA interactions, global regulatory agencies)
- Familiarity with target identification/prioritization through causal human biology in areas of high unmet need, translational endpoints, biomarker strategies, precision medicine approaches, clinical pharmacology, and pharmacokinetic/pharmacodynamic modeling
- Previous experience in autoimmune therapeutic areas (autoimmune, inflammatory, and allergic diseases within gastroenterology, rheumatology, dermatology, and respiratory specialties)
- Publication record in peer-reviewed journals demonstrating scientific leadership
- Experience with business development, licensing, or partnership activities
- Previous regulatory interactions and FDA or other health authority meeting experience
- Advanced degree or fellowship training in clinical research or pharmaceutical medicine
- Experience with innovative experimental medicine trial designs and adaptive study approaches
- Demonstrated ability to lead programs, influence strategy, and operate effectively in a fast-moving, high-visibility portfolio environment
Benefits
Comp & perks- 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
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
ATS Keywords
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Hard Skills & Tools
early-phase clinical trial designtranslational medicinebiomarker developmentimmunomodulatory approachesclinical pharmacologypharmacokinetic modelingpharmacodynamic modelingregulatory strategyIND submissionsdata analysis
Soft Skills
cross-functional collaborationmatrix leadershipstrategic leadershipmentoringdecision-makinginfluencingrelationship buildingcommunicationaccountabilitycollaboration
Certifications
Medical DoctorDoctor of Osteopathyboard certification in Rheumatologyboard certification in Dermatologyboard certification in Gastroenterologyboard certification in Allergy/Immunology