Medical Director - Physician -Early Clinical Development, Immunology

Lilly • San Diego, CA

6d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Summary We are seeking an exceptional physician scientist to join our Immunology team as Medical Director, Early Clinical Development. This role is designed for a clinical translational leader who can bridge the critical gap between discovery science and clinical application, driving the development of transformational medicines for patients with autoimmune and inflammatory diseases. The successful candidate will serve as a scientific catalyst, connecting discovery scientists, translational/biomarker experts, early clinical physicians, clinical pharmacologists, and late-stage clinicians to craft compelling therapeutic hypotheses and efficiently test them in early clinical development with line of sight to full development and approval. This role requires exceptional matrix leadership skills to influence cross-functional teams and advance both internal and external portfolio opportunities and bring transformational treatments to patients with autoimmune and inflammatory diseases.

Requirements

• 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).

Nice To Haves

• Minimum 3-5 years of pharmaceutical industry experience in 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 modelingPrevious experience in autoimmune therapeutic areas (autoimmune, inflammatory, and allergic diseases within the 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

Responsibilities

• Strategic Portfolio Leadership 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
• Clinical Development Excellence In collaboration with stakeholders, 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
• Cross-Functional Leadership & Influence 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
• External Partnerships & Scientific Exchange 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
• Regulatory & Medical Affairs Support 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

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
• Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees