Executive Medical Director - Physician -Early Clinical Development, Immunology
PharmaBiotechPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assurancemedicalgcpbiostatisticsregulatory submissionemafdacro
Job description
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 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 a high-impact physician scientist and emerging industry leader to join our Immunology team as Executive Medical Director, Early Clinical Development. This role is designed for a clinical translational leader ready to step into enterprise influence, bridging 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 strategic and scientific leader, 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 strong matrix leadership, executive presence, and the ability to inspire high-performing teams, influencing cross-functional partners and advancing both internal and external portfolio opportunities to bring transformational treatments to patients with autoimmune and inflammatory diseases. This position is ideal for a proven industry Director/Sr Director seeking broader leadership scope, enterprise visibility, and the opportunity to help build a dynamic and growing Immunology organization at Lilly. Primary 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 Act as a visible strategic leader within the immunology portfolio, influencing direction, investment decisions, and development priorities 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 Drive innovative experimental medicine approaches and accelerate progression from first-in-human through proof-of-concept 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 Operate as a culture-shaping leader who elevates performance, accountability, and collaboration across teams 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 Enhance Lilly’s external scientific presence as a thought partner and collaborator in immunology innovation 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 Help shape development strategy and regulatory positioning for early-stage immunology assets Minimum Qualifications 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). Preferred Qualifications 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 regula
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Key Account Manager R & I - Cluj
AstraZeneca — Romania - Bucharest
Plasma Center Technician
Takeda — USA - UT - American Fork
Plasma Center Technician (Open Availability Needed)
Takeda — USA - WA - Tukwila
Plasma Center Registered Nurse (RN)
Takeda — USA - WI - Onalaska
Plasma Center Receptionist
Takeda — USA - TX - San Antonio - Deza
Plasma Center Paramedic – EMT-P
Takeda — USA - MI - Holland