Medical Director - Physician -Early Clinical Development, Immunology

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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.

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

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

Minimum Qualifications

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in Rheumatology, Dermatology, Gastroenterology, Allergy/Immunology, Neurology (especially Multiple Sclerosis), 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 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

Key Competencies

Scientific Leadership:

• Ability to synthesize complex scientific data and translate into actionable clinical strategies
• Strategic thinking and hypothesis generation capabilities
• Critical evaluation of competitive landscape and market opportunities

Matrix Leadership & Influence:

• Exceptional communication and interpersonal skills
• Demonstrated ability to influence without authority and build consensus across diverse teams
• Strong negotiation and conflict resolution capabilities
• Cultural sensitivity and ability to work effectively in global environment

Execution Excellence:

• Autonomous work style with strong project management capabilities
• Results-oriented mindset with focus on patient impact and business objectives
• Adaptability and resilience in fast-paced, evolving environment
• Strong analytical and problem-solving skills

External Engagement:

• Ability to build and maintain relationships with external scientific and clinical community
• Strong presentation and public speaking capabilities
• Professional network within autoimmune/inflammatory disease research community

Additional information and expectations

• Travel: 25-40% domestic and international travel required
• Location: Indianapolis, Boston, San Diego, San Francisco, New York
• Reports to: head of Early Clinical Development, Immunology Discovery
• Matrix relationships: Extensive collaboration across Discovery, Translational Medicine, Clinical Pharmacology, Quantitative Systems Pharmacology, Clinical Operations, Regulatory Affairs, and Search and Evaluation/Business Development

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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